title: Comparison of Nicotinamide and Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

acronym: NICOREN

summary: The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in other biological parameters, vascular calcification and bone mass loss and on the clinical and biological tolerance and finally to explore the roles of metabolites of nicotinamide.

ReferenceCitation: Goldsmith D, Ritz E, Covic A. Vascular calcification: a stiff challenge for the nephrologist: does preventing bone disease cause arterial disease? Kidney Int. 2004 Oct;66(4):1315-33. Review.

ReferenceCitation: Foley RN, Parfrey PS, Sarnak MJ. Epidemiology of cardiovascular disease in chronic renal disease. J Am Soc Nephrol. 1998 Dec;9(12 Suppl):S16-23. Review.

ReferenceCitation: Kidney Disease Outcomes Quality Initiative (K/DOQI) Group. K/DOQI clinical practice guidelines for management of dyslipidemias in patients with kidney disease. Am J Kidney Dis. 2003 Apr;41(4 Suppl 3):I-IV, S1-91.

ReferenceCitation: Jungers P, Choukroun G, Robino C, Massy ZA, Taupin P, Labrunie M, Man NK, Landais P. Epidemiology of end-stage renal disease in the Ile-de-France area: a prospective study in 1998. Nephrol Dial Transplant. 2000 Dec;15(12):2000-6.

ReferenceCitation: Kalantar-Zadeh K, Block G, Humphreys MH, Kopple JD. Reverse epidemiology of cardiovascular risk factors in maintenance dialysis patients. Kidney Int. 2003 Mar;63(3):793-808. Review.

ReferenceCitation: Collins R, Armitage J, Parish S, Sleigh P, Peto R; Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet. 2003 Jun 14;361(9374):2005-16.

ReferenceCitation: London GM, Guérin AP, Marchais SJ, Métivier F, Pannier B, Adda H. Arterial media calcification in end-stage renal disease: impact on all-cause and cardiovascular mortality. Nephrol Dial Transplant. 2003 Sep;18(9):1731-40.

ReferenceCitation: Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18.

ReferenceCitation: Shahapuni I, Mansour J, Harbouche L, Maouad B, Benyahia M, Rahmouni K, Oprisiu R, Bonne JF, Monge M, El Esper N, Presne C, Moriniere P, Choukroun G, Fournier A. How do calcimimetics fit into the management of parathyroid hormone, calcium, and phosphate disturbances in dialysis patients? Semin Dial. 2005 May-Jun;18(3):226-38. Review.

ReferenceCitation: Ghazali A, Fardellone P, Pruna A, Atik A, Achard JM, Oprisiu R, Brazier M, Remond A, Morinière P, Garabedian M, Eastwood J, Fournier A. Is low plasma 25-(OH)vitamin D a major risk factor for hyperparathyroidism and Looser's zones independent of calcitriol? Kidney Int. 1999 Jun;55(6):2169-77.

ReferenceCitation: Goldsmith DJ, Covic A, Sambrook PA, Ackrill P. Vascular calcification in long-term haemodialysis patients in a single unit: a retrospective analysis. Nephron. 1997;77(1):37-43.

ReferenceCitation: Teng M, Wolf M, Lowrie E, Ofsthun N, Lazarus JM, Thadhani R. Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. N Engl J Med. 2003 Jul 31;349(5):446-56.

ReferenceCitation: Fournier AE, Johnson WJ, Taves DR, Beabout JW, Arnaud CD, Goldsmith RS. Etiology of hyperparathyroidism and bone disease during chronic hemodialysis. I. Association of bone disease with potentially etiologic factors. J Clin Invest. 1971 Mar;50(3):592-8.

ReferenceCitation: Argilés A, Kerr PG, Canaud B, Flavier JL, Mion C. Calcium kinetics and the long-term effects of lowering dialysate calcium concentration. Kidney Int. 1993 Mar;43(3):630-40.

ReferenceCitation: Indridason OS, Quarles LD. Comparison of treatments for mild secondary hyperparathyroidism in hemodialysis patients. Durham Renal Osteodystrophy Study Group. Kidney Int. 2000 Jan;57(1):282-92.

ReferenceCitation: Locatelli F, Covic A, Chazot C, Leunissen K, Luño J, Yaqoob M. Optimal composition of the dialysate, with emphasis on its influence on blood pressure. Nephrol Dial Transplant. 2004 Apr;19(4):785-96. Review.

ReferenceCitation: Chertow GM, Burke SK, Raggi P; Treat to Goal Working Group. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002 Jul;62(1):245-52.

ReferenceCitation: Fournier A, Said S, Ghazali A, Sechet A, Ezaitouni F, Marie A, Westeel PF, Morinière P, Boudailliez B. The clinical significance of adynamic bone disease in uremia. Adv Nephrol Necker Hosp. 1997;27:131-66. Review.

ReferenceCitation: London GM, Marty C, Marchais SJ, Guerin AP, Metivier F, de Vernejoul MC. Arterial calcifications and bone histomorphometry in end-stage renal disease. J Am Soc Nephrol. 2004 Jul;15(7):1943-51.

ReferenceCitation: Delmez JA, Tindira CA, Windus DW, Norwood KY, Giles KS, Nighswander TL, Slatopolsky E. Calcium acetate as a phosphorus binder in hemodialysis patients. J Am Soc Nephrol. 1992 Jul;3(1):96-102.

ReferenceCitation: Ben Hamida F, el Esper I, Compagnon M, Morinière P, Fournier A. Long-term (6 months) cross-over comparison of calcium acetate with calcium carbonate as phosphate binder. Nephron. 1993;63(3):258-62.

ReferenceCitation: Yang H, Curinga G, Giachelli CM. Elevated extracellular calcium levels induce smooth muscle cell matrix mineralization in vitro. Kidney Int. 2004 Dec;66(6):2293-9.

ReferenceCitation: Pörsti I, Fan M, Kööbi P, Jolma P, Kalliovalkama J, Vehmas TI, Helin H, Holthöfer H, Mervaala E, Nyman T, Tikkanen I. High calcium diet down-regulates kidney angiotensin-converting enzyme in experimental renal failure. Kidney Int. 2004 Dec;66(6):2155-66.

ReferenceCitation: Cozzolino M, Staniforth ME, Liapis H, Finch J, Burke SK, Dusso AS, Slatopolsky E. Sevelamer hydrochloride attenuates kidney and cardiovascular calcifications in long-term experimental uremia. Kidney Int. 2003 Nov;64(5):1653-61.

ReferenceCitation: Taal MW, Roe S, Masud T, Green D, Porter C, Cassidy MJ. Total hip bone mass predicts survival in chronic hemodialysis patients. Kidney Int. 2003 Mar;63(3):1116-20.

ReferenceCitation: Parfitt AM. Renal bone disease: a new conceptual framework for the interpretation of bone histomorphometry. Curr Opin Nephrol Hypertens. 2003 Jul;12(4):387-403. Review.

ReferenceCitation: Riggs BL, Parfitt AM. Drugs used to treat osteoporosis: the critical need for a uniform nomenclature based on their action on bone remodeling. J Bone Miner Res. 2005 Feb;20(2):177-84. Epub 2004 Nov 16. Review.

ReferenceCitation: Mansour J, Benyahia M, Harbouche L, Presne C, Moriniere P, Fournier A. Calcimetic AMG 073 at 50 and 100 mg per day. Kidney Int. 2003 Dec;64(6):2324-5.

ReferenceCitation: Manns B, Stevens L, Miskulin D, Owen WF Jr, Winkelmayer WC, Tonelli M. A systematic review of sevelamer in ESRD and an analysis of its potential economic impact in Canada and the United States. Kidney Int. 2004 Sep;66(3):1239-47. Review.

ReferenceCitation: Lacour B, Lucas A, Auchère D, Ruellan N, de Serre Patey NM, Drüeke TB. Chronic renal failure is associated with increased tissue deposition of lanthanum after 28-day oral administration. Kidney Int. 2005 Mar;67(3):1062-9. Erratum in: Kidney Int. 2005 Jul;68(1):427.

ReferenceCitation: Takahashi Y, Tanaka A, Nakamura T, Fukuwatari T, Shibata K, Shimada N, Ebihara I, Koide H. Nicotinamide suppresses hyperphosphatemia in hemodialysis patients. Kidney Int. 2004 Mar;65(3):1099-104.

ReferenceCitation: Renaud H, Atik A, Hervé M, Morinière P, Hocine C, Belbrik S, Fournier A. Evaluation of vascular calcinosis risk factors in patients on chronic hemodialysis: lack of influence of calcium carbonate. Nephron. 1988;48(1):28-32.

ReferenceCitation: Wanner C, Krane V, März W, Olschewski M, Asmus HG, Krämer W, Kühn KW, Kütemeyer H, Mann JF, Ruf G, Ritz E; Deutsche Diabetes-Dialyse-Studie (4D) Study Group. Randomized controlled trial on the efficacy and safety of atorvastatin in patients with type 2 diabetes on hemodialysis (4D study): demographic and baseline characteristics. Kidney Blood Press Res. 2004;27(4):259-66. Epub 2004 Aug 16.

ReferenceCitation: Gale EA, Bingley PJ, Emmett CL, Collier T; European Nicotinamide Diabetes Intervention Trial (ENDIT) Group. European Nicotinamide Diabetes Intervention Trial (ENDIT): a randomised controlled trial of intervention before the onset of type 1 diabetes. Lancet. 2004 Mar 20;363(9413):925-31.

ReferenceCitation: Moe SM, Chertow GM, Coburn JW, Quarles LD, Goodman WG, Block GA, Drüeke TB, Cunningham J, Sherrard DJ, McCary LC, Olson KA, Turner SA, Martin KJ. Achieving NKF-K/DOQI bone metabolism and disease treatment goals with cinacalcet HCl. Kidney Int. 2005 Feb;67(2):760-71.

ReferenceCitation: Kauppila LI, Polak JF, Cupples LA, Hannan MT, Kiel DP, Wilson PW. New indices to classify location, severity and progression of calcific lesions in the abdominal aorta: a 25-year follow-up study. Atherosclerosis. 1997 Jul 25;132(2):245-50.

ReferenceCitation: Wilson PW, Kauppila LI, O'Donnell CJ, Kiel DP, Hannan M, Polak JM, Cupples LA. Abdominal aortic calcific deposits are an important predictor of vascular morbidity and mortality. Circulation. 2001 Mar 20;103(11):1529-34.

ReferenceCitation: Kiel DP, Kauppila LI, Cupples LA, Hannan MT, O'Donnell CJ, Wilson PW. Bone loss and the progression of abdominal aortic calcification over a 25 year period: the Framingham Heart Study. Calcif Tissue Int. 2001 May;68(5):271-6. Erratum in: Calcif Tissue Int. 2004 Feb;74(2):208.

ReferenceCitation: Ureña P, Bernard-Poenaru O, Ostertag A, Baudoin C, Cohen-Solal M, Cantor T, de Vernejoul MC. Bone mineral density, biochemical markers and skeletal fractures in haemodialysis patients. Nephrol Dial Transplant. 2003 Nov;18(11):2325-31.

ReferenceCitation: Genant HK, Wu CY, van Kuijk C, Nevitt MC. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res. 1993 Sep;8(9):1137-48.

ReferenceCitation: Grados F, Roux C, de Vernejoul MC, Utard G, Sebert JL, Fardellone P. Comparison of four morphometric definitions and a semiquantitative consensus reading for assessing prevalent vertebral fractures. Osteoporos Int. 2001;12(9):716-22.

ReferenceCitation: Malluche M, Monier-faugère M, wang G, Frazao J, Coburn J, Baker N, McCary LC, Turner JA, Goodman WG: Cinaclacet Hcl reduces bone turn over and bone marrow fibrosa in hemodialysis patients with secondary hyperparathyroidism. ERA XLI congress. AbstractBook Lisboa:P218 (M016), 2004

ReferenceCitation: Dament J,Gill M, Confer S, Jones C, Webster J: The bone kinetics of lanthanum in dialysis patient treated with lanthanum carbonate up to 45 years. J Am Soc Nephrol 15 (Abstract):271A (poster FPO 948), 2004

ReferenceCitation: Malluche M, Faugère MC, Damment SJP, Webster I: No osteomalacia in dialysis patients treated with lanthanum carbonate up to 4.5 years. J Am Soc Nephrol 15 (supplt Abstract):p270A Poster F P0944,2004

ReferenceCitation: De Smet R, Thermote F, Lameire N, Vanholder R: SEVELAMER hydrochloride (Renagel(r)) adsorbs the uremic compounds indoxyl sulfate, indole and p-creso.[Abstract]. J Am Soc Nephrol 15, 2004

ReferenceCitation: Block GA, Martin KJ, de Francisco AL, Turner SA, Avram MM, Suranyi MG, Hercz G, Cunningham J, Abu-Alfa AK, Messa P, Coyne DW, Locatelli F, Cohen RM, Evenepoel P, Moe SM, Fournier A, Braun J, McCary LC, Zani VJ, Olson KA, Drüeke TB, Goodman WG. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004 Apr 8;350(15):1516-25.

ReferenceCitation: Alsheikh-Ali A, Aboujaily HM, Stanek LJ, coll. e: Increases in HDL cholesterol are the strongest predictions of risk reduction in lipid intervention trials. Circulation 111 (suppltIII):813 Abstract 3754,2004

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Association Régionale Promotion Dialyse à domicile (ARPDD)

location_facility: Association pour le Développement de l'Hémodialyse


title: Factors Determining Quality of Life Related to Respiratory Status According to Gender of COPD Patients Followed by a Pneumologist

acronym: VITALITE

summary: The purpose of this study is to evaluate with sufficient precision and according to gender the determining independent factors of quality of life related to respiratory status of patient with moderate to severe COPD.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

lead_sponsor: AstraZeneca

lead_sponsor_type: industriel

status_simplified: Completed


title: Impact of the Use of a Computerized Protocol for Glucose Control Named CGAOtm on the Outcome of Critically Ill Patients

acronym: CGAO-REA

summary: The aim of the study is to determine whether the use of the CGAOtm software is associated with a decrease in 90-day mortality when compared with the use of standard care methods for glucose control with target blood glucose levels inferior to 180 mg/dl. The CGAOtm software is designed to assist physicians and nurses in achieving tight glucose control (defined by a target for blood glucose levels between 80 and 110 mg/dl) in critically ill patients.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Carli P, Martin C. [Impact of Nice-Sugar: is there a need for another study on intensive glucose control in ICU?]. Ann Fr Anesth Reanim. 2009 Jun;28(6):519-21. doi: 10.1016/j.annfar.2009.05.002. Epub 2009 Jun 4. French.

ReferenceCitation: Guerrini A; Roudillon G; Gontier O; Rebaï L; Isorni MA; Mutinelli-Szymanski P; Sorine M; Kalfon P. High glycemic variability induced by inappropriate algorithms for intensive insulinotherapy: the example of the NICE-SUGAR study. Abstract award winners: The best pre-selected abstracts of the 22th Annual Congress of the European Society of Intensive Care Medicine, 11-14 October 2009, Vienna, Austria. Intensive Care Med. 2009 Sep;35 Suppl 1:S111.

ReferenceCitation: Gontier O; Hamrouni M; Lherm T; Monchamps G; Ouchenir A; Kalfon P. The CGAO software improves glycaemic control in intensive care patients without increasing the incidence of severe hypoglycaemia nor the nurse workload. Abstracts of the 21th Annual Congress of the European Society of Intensive Care Medicine, 21-24 September 2007, Lisbon, Portugal. Intensive Care Med. 2008 Sep;34 Suppl 2:S220.

ReferenceCitation: Kalfon P; Marie C; Gontier O; Riou B. Improvement of glycaemic control in critically ill patients with the software CGAO. Abstract of the 20th Annual Congress of the European Society of Intensive Care Medicine, 7-10 October 2007, Berlin, Germany. Intensive Care Med. 2007 Sep;33 Suppl 2:S54.

ReferenceType: derived

ReferenceCitation: Kalfon P, Le Manach Y, Ichai C, Bréchot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, Riou B; CGAO-REA Study Group. Severe and multiple hypoglycemic episodes are associated with increased risk of death in ICU patients. Crit Care. 2015 Apr 8;19:153. doi: 10.1186/s13054-015-0851-7.

family: Kalfon

full_name: Pierre Kalfon

given: Pierre

sequence: first

family: Le Manach

full_name: Yannick Le Manach

given: Yannick

sequence: additional

family: Ichai

full_name: Carole Ichai

given: Carole

family: Bréchot

full_name: Nicolas Bréchot

given: Nicolas

family: Cinotti

full_name: Raphaël Cinotti

given: Raphaël

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

family: Riu-Poulenc

full_name: Béatrice Riu-Poulenc

given: Béatrice

family: Montravers

full_name: Philippe Montravers

given: Philippe

family: Annane

full_name: Djilalli Annane

given: Djilalli

family: Dupont

full_name: Hervé Dupont

given: Hervé

family: Sorine

full_name: Michel Sorine

given: Michel

family: Riou

full_name: Bruno Riou

given: Bruno

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Critical Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Artxiker

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

ReferenceCitation: Kalfon P, Giraudeau B, Ichai C, Guerrini A, Brechot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, Riou B; CGAO-REA Study Group. Tight computerized versus conventional glucose control in the ICU: a randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):171-81. doi: 10.1007/s00134-013-3189-0. Epub 2014 Jan 14.

location_facility: CHU de Bordeaux - Groupe Hospitalier Sud, Hôpital Haut Lévêque

location_facility: Centre Hospitalier Départemental Les Oudairies


title: Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO

summary: This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is >100.

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug


type: Other Identifier

title: Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie LUCIEN NEUWIRTH

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Institut de Cancérologie de l'Ouest Paul Papin

intervention_type: Radiation

status_simplified: Ongoing


title: Open-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)

summary: This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is <500 individuals.

ReferenceCitation: Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikström A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol. 2013 Aug 20;31(24):3004-11. doi: 10.1200/JCO.2012.42.3749. Epub 2013 Jul 8.

name: Fabrice Barlesi, Aix Marseille University–Assistance Publique Hôpitaux de Marseille and Centre d'Investigation Clinique, Marseille; Arnaud Scherpereel, Hôpital Calmette, Centre Hospitalier Régional Universitaire de Lille, Lille, France; Achim Rittmeyer, Lungenfachklinik Immenhausen, Immenhausen, Germany; Antonio Pazzola, Ospedale Civile Santissima, Annunziata, Sassari, Italy; Neus Ferrer Tur, Hospital Son Llàtzer, Palma de Majorca, Spain; Joo-Hang Kim, Yonsei University College of Medicine; Myung-Ju Ahn,...

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

family: Rittmeyer

full_name: Achim Rittmeyer

given: Achim

family: Pazzola

full_name: Antonio Pazzola

given: Antonio

family: Ferrer Tur

full_name: Neus Ferrer Tur

given: Neus

family: Kim

full_name: Joo-Hang Kim

given: Joo-Hang

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

family: Aerts

full_name: Joachim G.J.V. Aerts

given: Joachim G.J.V.

family: Gorbunova

full_name: Vera Gorbunova

given: Vera

family: Vikström

full_name: Anders Vikström

given: Anders

family: Wong

full_name: Elaine K. Wong

given: Elaine K.

family: Perez-Moreno

full_name: Pablo Perez-Moreno

given: Pablo

family: Mitchell

full_name: Lada Mitchell

given: Lada

family: Groen

full_name: Harry J.M. Groen

given: Harry J.M.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Randomized Phase III Trial of Maintenance Bevacizumab With or Without Pemetrexed After First-Line Induction With Bevacizumab, Cisplatin, and Pemetrexed in Advanced Nonsquamous Non–Small-Cell Lung Cancer: AVAPERL (MO22089)

location_country:
Italy
Sweden
United Arab Emirates
Switzerland
Netherlands
France
Greece
Russian Federation
Spain
Turkey
Germany
Korea, Republic of


intervention_type: Other

status: Terminated

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospital Regional Universitaire de Limoges

type: EudraCT Number

source: euctr

title: Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.

status_simplified: Unknown


title: Multicenter Phase III Randomized Study of FOLFIRI Plus Bevacizumab Following or Not by a Maintenance Therapy With Bevacizumab in Patients With Non-Pretreated Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given with or without bevacizumab in treating patients with metastatic colorectal cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or without bevacizumab to see how well it works in treating patients with metastatic colorectal cancer.

ReferenceCitation: Aparicio T, Linot B, Le Malicot K, Bouché O, Boige V, François E, Ghiringhelli F, Legoux JL, Ben Abdelghani M, Phelip JM, Faroux R, Dahan L, Taieb J, Bedenne L. FOLFIRI+bevacizumab induction chemotherapy followed by bevacizumab or observation in metastatic colorectal cancer, a phase III trial (PRODIGE 9--FFCD 0802). Dig Liver Dis. 2015 Apr;47(4):271-2. doi: 10.1016/j.dld.2015.01.146. Epub 2015 Jan 20.

ReferenceType: result

ReferenceCitation: Aparicio T, Ghiringhelli F, Boige V, Le Malicot K, Taieb J, Bouché O, Phelip JM, François E, Borel C, Faroux R, Dahan L, Jacquot S, Genet D, Khemissa F, Suc E, Desseigne F, Texereau P, Lepage C, Bennouna J; PRODIGE 9 Investigators. Bevacizumab Maintenance Versus No Maintenance During Chemotherapy-Free Intervals in Metastatic Colorectal Cancer: A Randomized Phase III Trial (PRODIGE 9). J Clin Oncol. 2018 Mar 1;36(7):674-681. doi: 10.1200/JCO.2017.75.2931. Epub 2018 Jan 18.

name: Thomas Aparicio, Centre Hospitalier Universitaire (CHU) Saint Louis, Assistance Public Hôpitaux de Paris (APHP), and Université Paris 7, Sorbonne Paris Cité; Julien Taieb, Hôpital Européen Georges Pompidou, Paris; Francois Ghiringhelli, Centre Georges-François Leclerc; Karine Le Malicot, Fédération Francophone de Cancérologie Digestive; Come Lepage, CHU Le Bocage, Institut National de la Santé et de la Recherche Médicale Unité Mixte de Recherche (UMR) 1231, Dijon; Valérie Boige, Institut Gustave Roussy,...

family: Aparicio

full_name: Thomas Aparicio

given: Thomas

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

family: Boige

full_name: Valérie Boige

given: Valérie

family: Le Malicot

full_name: Karine Le Malicot

given: Karine

family: Taieb

full_name: Julien Taieb

given: Julien

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Phelip

full_name: Jean-Marc Phelip

given: Jean-Marc

family: François

full_name: Eric François

given: Eric

family: Borel

full_name: Christian Borel

given: Christian

family: Faroux

full_name: Roger Faroux

given: Roger

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

family: Jacquot

full_name: Stéphane Jacquot

given: Stéphane

family: Genet

full_name: Dominique Genet

given: Dominique

family: Khemissa

full_name: Faiza Khemissa

given: Faiza

family: Suc

full_name: Etienne Suc

given: Etienne

family: Desseigne

full_name: Françoise Desseigne

given: Françoise

family: Texereau

full_name: Patrick Texereau

given: Patrick

family: Lepage

full_name: Come Lepage

given: Come

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Aparicio T, Bennouna J, Le Malicot K, Boige V, Taieb J, Bouché O, Phelip JM, François E, Borel C, Faroux R, Dahan L, Bachet JB, Egreteau J, Kaminsky MC, Gornet JM, Cojocarasu O, Gasmi M, Guerin-Meyer V, Lepage C, Ghiringhelli F; for PRODIGE investigators/collaborators. Predictive factors for early progression during induction chemotherapy and chemotherapy-free interval: analysis from PRODIGE 9 trial. Br J Cancer. 2020 Mar;122(7):957-962. doi: 10.1038/s41416-020-0735-8. Epub 2020 Feb 4.

ReferenceCitation: Guilloteau A, Abrahamowicz M, Boussari O, Jooste V, Aparicio T, Quantin C, Le Malicot K, Binquet C. Impact of time-varying cumulative bevacizumab exposures on survival: re-analysis of data from randomized clinical trial in patients with metastatic colo-rectal cancer. BMC Med Res Methodol. 2021 Jan 9;21(1):14. doi: 10.1186/s12874-020-01202-9.

ReferenceCitation: Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouché O, François E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2020 Mar;69(3):531-539. doi: 10.1136/gutjnl-2018-316407. Epub 2019 May 17.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Radiothérapie et Oncologie de Moyenne Garonne

location_facility: Clinique Valdegour, Centre ONCOGARD - Institut de Cancérologie du Gard


title: A Randomized Phase II Study of Clofarabine / Intermediate-Dose Cytarabine (CLARA)Versus High-Dose Cytarabine (HDAC) as Consolidation in Younger Patients With Newly-Diagnosed Acute Myeloid Leukemia (AML).

acronym: CLARA

summary:
This study is a phase II randomized multicenter study. Patients will be enrolled at time of diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without indication of intensification by allogeneic stem cell transplantation and/or without HLA (Human Leukocyte Antigen)-compatible donor, who attain a CR after one or two cycles of induction chemotherapy, will be eligible for the study Clofarabine / Intermediate-Dose Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC)and will be randomized between 3 courses of CLARA chemotherapy and 3 courses of HDAC chemotherapy as consolidation.

We will compare efficacy and toxicity among the two arms.

ReferenceCitation: Fenwarth L, Thomas X, de Botton S, Duployez N, Bourhis JH, Lesieur A, Fortin G, Meslin PA, Yakoub-Agha I, Sujobert P, Dumas PY, Récher C, Lebon D, Berthon C, Michallet M, Pigneux A, Nguyen S, Chantepie S, Vey N, Raffoux E, Celli-Lebras K, Gardin C, Lambert J, Malfuson JV, Caillot D, Maury S, Ducourneau B, Turlure P, Lemasle E, Pautas C, Chevret S, Terré C, Boissel N, Socié G, Dombret H, Preudhomme C, Itzykson R. A personalized approach to guide allogeneic stem cell transplantation in younger adults with acute myeloid leukemia. Blood. 2021 Jan 28;137(4):524-532. doi: 10.1182/blood.2020005524.

name: Unité Mixte de Recherche (UMR) 9020–UMR1277, Canther–Cancer Heterogeneity, Plasticity and Resistance to Therapies, University of Lille, Centre National de la Recherche Scientifique (CNRS), INSERM, Centre Hospitalo-Universitaire (CHU) Lille, Institut de Recherche sur le Cancer de Lille (IRCL), Lille, France;

family: Fenwarth

full_name: Laurène Fenwarth

given: Laurène

name: Service d'Hématologie Clinique, Hospices Civils de Lyon, Hôpital Lyon Sud, Pierre-Bénite, France;

family: Thomas

full_name: Xavier Thomas

given: Xavier

name: Département d’Hématologie, Institut Gustave Roussy, Villejuif, France;

family: de Botton

full_name: Stéphane de Botton

family: Duployez

full_name: Nicolas Duployez

given: Nicolas

family: Bourhis

full_name: Jean-Henri Bourhis

given: Jean-Henri

family: Lesieur

full_name: Auriane Lesieur

given: Auriane

name: Université de Paris, Génomes, Biologie Cellulaire et Thérapeutique U944, INSERM, CNRS, Paris, France;

family: Fortin

full_name: Gael Fortin

given: Gael

family: Meslin

full_name: Paul-Arthur Meslin

given: Paul-Arthur

name: CHU de Lille, University of Lille, INSERM U1286, Infinite, Lille, France;

family: Yakoub-Agha

full_name: Ibrahim Yakoub-Agha

given: Ibrahim

name: Service d'Hématologie Biologique, Hospices Civils de Lyon, Hôpital Lyon Sud, Pierre-Bénite, France;

family: Sujobert

full_name: Pierre Sujobert

given: Pierre

name: Service d’Hématologie et Thérapie Cellulaire, CHU Bordeaux, Bordeaux, France;

family: Dumas

full_name: Pierre-Yves Dumas

given: Pierre-Yves

name: Service d’Hématologie, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer Toulouse–Oncopole, Toulouse, France;

family: Récher

full_name: Christian Récher

name: Service d’Hématologie Clinique, CHU Amiens, Amiens, France;

family: Lebon

full_name: Delphine Lebon

given: Delphine

name: Service d’Hématologie, CHU Lille, Lille, France;

family: Berthon

full_name: Céline Berthon

given: Céline

family: Michallet

full_name: Mauricette Michallet

given: Mauricette

family: Pigneux

full_name: Arnaud Pigneux

given: Arnaud

name: Service d’Hématologie Clinique, Hôpital Pitié-Salpétrière, Assistance Publique–Hôpitaux de Paris (AP-HP), Paris, France;

family: Nguyen

full_name: Stéphanie Nguyen

given: Stéphanie

name: Service d’Hématologie Clinique, CHU Caen, Caen, France;

family: Chantepie

full_name: Sylvain Chantepie

given: Sylvain

name: Service d’Hématologie, Institut Paoli-Calmettes, Marseille, France;

family: Vey

full_name: Norbert Vey

given: Norbert

name: Service Hématologie Adultes, Hôpital Saint-Louis, AP-HP, Paris, France;

family: Raffoux

full_name: Emmanuel Raffoux

given: Emmanuel

name: Acute Leukemia French Association Coordination Office, Institut de Recherche Saint-Louis (IRSL), Hôpital Saint-Louis, Paris, France;

family: Celli-Lebras

full_name: Karine Celli-Lebras

name: Service d’Hématologie Clinique, Hôpital Avicenne, AP-HP, Bobigny, France;

family: Gardin

full_name: Claude Gardin

given: Claude

name: Département d'Hématologie Clinique, Hôpital André Mignot, Centre Hospitalier de Versailles, Le Chesnay, France;

family: Lambert

full_name: Juliette Lambert

given: Juliette

name: Service d’Hématologie Clinique, Hôpital d’Instruction des Armées Percy, Clamart, France;

name: Service d’Hématologie Clinique, CHU Dijon, Dijon, France;

name: Service d’Hématologie Clinique, Hôpital Henri Mondor, AP-HP, Créteil, France;

name: Laboratoire d’Hématologie, CH Valenciennes, Valenciennes, France;

name: Service d’Hématologie Clinique, CHU Limoges, Limoges, France;

name: Service d’Hématologie, Centre Henri Becquerel, Rouen, France;

name: Service de Biostatistiques et Informatique Médicale, Hôpital Saint-Louis, AP-HP, Paris, France;

name: Laboratoire d’Hématologie, CH Versailles, Le Chesnay, France; and

name: Service Hématologie Adolescents Jeunes Adultes and

name: Service Hématologie Greffe, Hôpital Saint-Louis, AP-HP, Paris, France

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud


ReferenceCitation: Pujol JL, Breton JL, Gervais R, Tanguy ML, Quoix E, David P, Janicot H, Westeel V, Gameroff S, Genève J, Maraninchi D. Phase III double-blind, placebo-controlled study of thalidomide in extensive-disease small-cell lung cancer after response to chemotherapy: an intergroup study FNCLCC cleo04 IFCT 00-01. J Clin Oncol. 2007 Sep 1;25(25):3945-51.

ReferenceCitation: Pujol JL, Daurès JP, Rivière A, Quoix E, Westeel V, Quantin X, Breton JL, Lemarié E, Poudenx M, Milleron B, Moro D, Debieuvre D, Le Chevalier T. Etoposide plus cisplatin with or without the combination of 4'-epidoxorubicin plus cyclophosphamide in treatment of extensive small-cell lung cancer: a French Federation of Cancer Institutes multicenter phase III randomized study. J Natl Cancer Inst. 2001 Feb 21;93(4):300-8.

ReferenceCitation: Horn L, Dahlberg SE, Sandler AB, Dowlati A, Moore DF, Murren JR, Schiller JH. Phase II study of cisplatin plus etoposide and bevacizumab for previously untreated, extensive-stage small-cell lung cancer: Eastern Cooperative Oncology Group Study E3501. J Clin Oncol. 2009 Dec 10;27(35):6006-11. doi: 10.1200/JCO.2009.23.7545. Epub 2009 Oct 13.

ReferenceCitation: Pujol JL, Lavole A, Quoix E, Molinier O, Souquet PJ, Barlesi F, Le Caer H, Moro-Sibilot D, Fournel P, Oster JP, Chatellain P, Barre P, Jeannin G, Mourlanette P, Derollez M, Herman D, Renault A, Dayen C, Lamy PJ, Langlais A, Morin F, Zalcman G; French Cooperative Thoracic Intergroup (IFCT). Randomized phase II-III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer: results from the IFCT-0802 trial†. Ann Oncol. 2015 May;26(5):908-914. doi: 10.1093/annonc/mdv065. Epub 2015 Feb 16.

family: Pujol

full_name: J.-L. Pujol

family: Lavole

full_name: A. Lavole

given: A.

family: Quoix

full_name: E. Quoix

given: E.

family: Molinier

full_name: O. Molinier

given: O.

family: Souquet

full_name: P.-J. Souquet

family: Barlesi

full_name: F. Barlesi

given: F.

family: Le Caer

full_name: H. Le Caer

given: H.

family: Moro-Sibilot

full_name: D. Moro-Sibilot

given: D.

family: Fournel

full_name: P. Fournel

given: P.

family: Oster

full_name: J.P. Oster

family: Chatellain

full_name: P. Chatellain

family: Barre

full_name: P. Barre

family: Jeannin

full_name: G. Jeannin

given: G.

family: Mourlanette

full_name: P. Mourlanette

family: Derollez

full_name: M. Derollez

given: M.

family: Herman

full_name: D. Herman

family: Renault

full_name: A. Renault

family: Dayen

full_name: C. Dayen

given: C.

family: Lamy

full_name: P.J. Lamy

family: Langlais

full_name: A. Langlais

family: Morin

full_name: F. Morin

family: Zalcman

full_name: G. Zalcman

family: Westeel

full_name: V. Westeel

given: V.

family: Poudenx

full_name: M. Poudenx

family: Mazieres

full_name: J. Mazieres

given: J.

title: Randomized phase II–III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer: results from the IFCT-0802 trial

ReferenceCitation: Negre E, Coffy A, Langlais A, Daures JP, Lavole A, Quoix E, Molinier O, Greillier L, Audigier-Valette C, Moro-Sibilot D, Westeel V, Morin F, Roch B, Pujol JL. Development and Validation of a Simplified Prognostic Score in SCLC. JTO Clin Res Rep. 2020 Feb 12;1(1):100016. doi: 10.1016/j.jtocrr.2020.100016. eCollection 2020 Mar.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Annemasse - CH
Colmar - CH
Harfleur - Clinique du Petit Colmoulins
Maubeuge - Polyclinique du Parc
Chauny - CH
Mont de Marsan - CH
Dijon - CHU
Clermont Ferrand - CHU
Reims - CRLCC
Toulon - HIA
Créteil - CHI
Centre F. Baclesse
Cahors - CH
Hôpital Percy-Armées - Pneumologie
Tours - CHU
APHM - Hôpital Sainte Marguerite
Reims - CHU
Montpellier - CHRU
Saint Brieuc - CHG
Nevers - CH
APHP - Hopital Tenon - Pneumologie
Pau - CH
Toulouse - Clinique Pasteur
Senlis - CH
CHU Toulouse - Pneumologie
APHP - Saint-Antoine - pneumologie
Dijon - CAC
Draguignan - CH
Armentières - CH
Angers - CHU
Suresnes - Hopital Foch
Chalons-en-Champagne - CH
CH - Compiègne
Nancy - CHU
Saint Priest en Jarez - ICL
Rouen - CHU
Jonzac - CH
Vesoul - CHI
CHU Besancon - Pneumologie
Metz - CHR
Neuilly - Hôpital Américain de Paris
CHU Grenoble - pneumologie
Thonon les bains
Saverne - CH
Institut Gustave Roussy
Saint Quentin - CH
Saint Nazaire - Centre Etienne Dolet
HCL - Lyon Sud (Pneumologie)
Centre Hospitalier - Pneumologie
Nouvel Hopital Civil - Pneumologie
Chartres - CH
Saint Omer - CHI
CH
CHU - Pneumologie
Marseille - CRLCC
Nice - CAC
Meaux - CH
Orléans - CH
Verdun - CHG
Mulhouse - CH

title: Randomized Phase II-III Study of Bevacizumab 7,5 mg/kg in Combination With Chemotherapy Versus Chemotherapy in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy : PCDE (cisPlatin - Cyclophosphamide - epiDoxorubicin - Etoposide) or PE (cisPlatin - Etoposide)

summary:
Despite the fact that a substantial response rate may be obtained in small-cell lung cancers (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More aggressive regimens remain controversial and recent attempts at increasing dose-intensity have been restricted to patients with a more favourable presentation.

Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial Growth Factor). In association with double-drug standard chemotherapies, it has been proven that bevacizumab can improve survival of previously untreated advanced non-small-cell lung cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on NSCLC deserve to be tested on small-cell lung cancers.

In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC patients.


title: A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old.

summary: The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.

ReferenceCitation: Muresan B, Mamolo C, Cappelleri JC, Mokgokong R, Palaka A, Soikkeli F, Heeg B. Comparing cure rates for gemtuzumab ozogamicin plus standard chemotherapy vs standard chemotherapy alone in acute myeloid leukemia patients. Future Oncol. 2021 Aug;17(22):2883-2892. doi: 10.2217/fon-2020-1287. Epub 2021 Apr 16.

name: Ingress Health, Rotterdam, 3012, The Netherlands

family: Muresan

full_name: Bogdan Muresan

given: Bogdan

family: Mamolo

full_name: Carla Mamolo

given: Carla

family: Cappelleri

full_name: Joseph C Cappelleri

given: Joseph C

family: Mokgokong

full_name: Ruth Mokgokong

given: Ruth

family: Palaka

full_name: Athina Palaka

given: Athina

family: Soikkeli

full_name: Fanni Soikkeli

given: Fanni

family: Heeg

full_name: Bart Heeg

given: Bart

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Renneville A, Abdelali RB, Chevret S, Nibourel O, Cheok M, Pautas C, Duléry R, Boyer T, Cayuela JM, Hayette S, Raffoux E, Farhat H, Boissel N, Terre C, Dombret H, Castaigne S, Preudhomme C. Clinical impact of gene mutations and lesions detected by SNP-array karyotyping in acute myeloid leukemia patients in the context of gemtuzumab ozogamicin treatment: results of the ALFA-0701 trial. Oncotarget. 2014 Feb 28;5(4):916-32.

lead_sponsor: Acute Leukemia French Association

location_facility:
Hopital Avicenne
CH
Hospital Central
Hopital Pitie-Salpetriere
Hopital Edouard Herriot
CNLCC
Hopital Saint-Louis
CHU
Hopital Percy
IGR


title: Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas.

acronym: MRP

summary: This multicentric prospective study evaluates the role of the margins resection and the ganglionic status when using a quality standard for the resection of adenocarcinoma of the head of the pancreas.

ReferenceCitation: Delpero JR, Jeune F, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Adham M, Autret A, Poizat F, Turrini O, Boher JM. Prognostic Value of Resection Margin Involvement After Pancreaticoduodenectomy for Ductal Adenocarcinoma: Updates From a French Prospective Multicenter Study. Ann Surg. 2017 Nov;266(5):787-796. doi: 10.1097/SLA.0000000000002432.

family: Delpero

full_name: Jean Robert Delpero

given: Jean Robert

family: Jeune

full_name: Florence Jeune

given: Florence

family: Bachellier

full_name: Philippe Bachellier

given: Philippe

family: Regenet

full_name: Nicolas Regenet

given: Nicolas

family: Le Treut

full_name: Yves Patrice Le Treut

given: Yves Patrice

family: Paye

full_name: Francois Paye

given: Francois

family: Carrere

full_name: Nicolas Carrere

family: Sauvanet

full_name: Alain Sauvanet

given: Alain

family: Adham

full_name: Mustapha Adham

given: Mustapha

family: Autret

full_name: Aurelie Autret

given: Aurelie

family: Poizat

full_name: Flora Poizat

given: Flora

family: Turrini

full_name: Olivier Turrini

given: Olivier

family: Boher

full_name: Jean Marie Boher

given: Jean Marie

journal_name: Annals of Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Delpero JR, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Autret A, Turrini O, Monges-Ranchin G, Boher JM. Pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: a French multicentre prospective evaluation of resection margins in 150 evaluable specimens. HPB (Oxford). 2014 Jan;16(1):20-33. doi: 10.1111/hpb.12061. Epub 2013 Mar 7.

full_name: François Paye

given: François

full_name: Aurélie Autret

given: Aurélie

location_facility:
Chu de Bordeaux
Hospices Civils de Lyon
Institut Paoli-Calmettes
Chu de Clermont-Ferrand
Hopital Henri Mondor
Hopital Cochin
Hopitial Saint Antoine
Hopital de L'Antiquaille
Hopital Beaujon
Chu D'Angers
Hotel Dieu
Hopital Pitie-Salpetriere
Hopital Ambroise Pare
Hopital de La Croix-Rousse
Centre Val D'Aurelle Paul Lamarque
Hopitaux Universitaires de Strasbourg
Chu La Conception
Hopital Pontchaillou
Chu Purpan
Hopital Tenon


title: Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey

acronym: PANORAMA

summary: The present European survey seeks to assess quality of life and satisfaction with treatment in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia and level of glycaemic control. It will also provide relevant information on other important aspects such as the level of correlation of objective measures such as HbA1c with health status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients will be invited to participate from a representative sample of clinical practices during a pre-specified period. The study will entail a single patient visit. Patients who agree to the study and give their informed consent will complete questionnaires which, combined with retrospective notes review & an HbA1c test, will allow patient, disease and treatment variables to be collected. An HbA1c test is a finger prick test to measure glycosylated haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.

ReferenceCitation: Bradley C, Eschwège E, de Pablos-Velasco P, Parhofer KG, Simon D, Vandenberghe H, Gönder-Frederick L. Predictors of Quality of Life and Other Patient-Reported Outcomes in the PANORAMA Multinational Study of People With Type 2 Diabetes. Diabetes Care. 2018 Feb;41(2):267-276. doi: 10.2337/dc16-2655. Epub 2017 Nov 28.

family: Bradley

full_name: Clare Bradley

given: Clare

family: Eschwège

full_name: Eveline Eschwège

given: Eveline

family: de Pablos-Velasco

full_name: Pedro de Pablos-Velasco

given: Pedro

family: Parhofer

full_name: Klaus G. Parhofer

given: Klaus G.

family: Simon

full_name: Dominique Simon

given: Dominique

family: Vandenberghe

full_name: Hans Vandenberghe

given: Hans

family: Gönder-Frederick

full_name: Linda Gönder-Frederick

given: Linda

journal_name: Diabetes Care

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Simon D, de Pablos-Velasco P, Parhofer KG, Gönder-Frederick L, Duprat Lomon I, Vandenberghe H, Eschwège E, Bradley C. Hypoglycaemic episodes in patients with type 2 diabetes--risk factors and associations with patient-reported outcomes: The PANORAMA Study. Diabetes Metab. 2015 Dec;41(6):470-9. doi: 10.1016/j.diabet.2015.08.007. Epub 2015 Oct 9.

full_name: D. Simon

given: D.

full_name: P. de Pablos-Velasco

given: P.

full_name: K.G. Parhofer

full_name: L. Gönder-Frederick

given: L.

family: Duprat Lomon

full_name: I. Duprat Lomon

given: I.

full_name: H. Vandenberghe

given: H.

full_name: E. Eschwège

given: E.

full_name: C. Bradley

given: C.

journal_name: Diabetes & Metabolism

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Hypoglycaemic episodes in patients with type 2 diabetes – risk factors and associations with patient-reported outcomes: The PANORAMA Study

ReferenceCitation: de Pablos-Velasco P, Parhofer KG, Bradley C, Eschwège E, Gönder-Frederick L, Maheux P, Wood I, Simon D. Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study. Clin Endocrinol (Oxf). 2014 Jan;80(1):47-56. doi: 10.1111/cen.12119. Epub 2013 May 6.

name: Dr Negrin Hospital; Las Palmas University; Las Palmas de Gran Canaria Spain

name: Medizinische Klinik II - Grosshadern; Klinikum der Universität München; Munich Germany

full_name: Klaus G Parhofer

given: Klaus G

name: Department of Psychology; Royal Holloway; University of London; Surrey United Kingdom

name: INSERM; Faculty of Medicine PARIS XI; Department of Epidemiology and Public Health UMR-S 1018; Villejuif France

name: Department of Psychiatry and Neurobehavioral Sciences; Behavioral Medicine Center; University of Virginia Health System; Virginia USA

name: AstraZeneca; Medical Europe; Zaventem Belgium

name: Bristol-Myers Squibb; Uxbridge; Middlesex UK

name: CESP; INSERM U-1018 Villejuif and Service de Diabétologie; Hôpital de la Pitié ; Paris France

ReferenceCitation: Bradley C, de Pablos-Velasco P, Parhofer KG, Eschwège E, Gönder-Frederick L, Simon D. PANORAMA: a European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus--study design. Prim Care Diabetes. 2011 Dec;5(4):231-9. doi: 10.1016/j.pcd.2011.04.004. Epub 2011 Jul 14.

title: PANORAMA: A European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus—Study design

location_country:
Italy
Netherlands
France
Greece
Ireland
Spain
Germany
United Kingdom


title: High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response

summary: The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years.

time_perspective: Prospective

ReferenceCitation: Dupuis J, Berriolo-Riedinger A, Julian A, Brice P, Tychyj-Pinel C, Tilly H, Mounier N, Gallamini A, Feugier P, Soubeyran P, Colombat P, Laurent G, Berenger N, Casasnovas RO, Vera P, Paone G, Xerri L, Salles G, Haioun C, Meignan M. Impact of [(18)F]fluorodeoxyglucose positron emission tomography response evaluation in patients with high-tumor burden follicular lymphoma treated with immunochemotherapy: a prospective study from the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS. J Clin Oncol. 2012 Dec 10;30(35):4317-22. doi: 10.1200/JCO.2012.43.0934. Epub 2012 Oct 29.

name: Jehan Dupuis, Corinne Haioun, and Michel Meignan, Hôpital Henri Mondor, Créteil; Alina Berriolo-Riedinger, Centre Georges Francois Leclerc; Rene-Olivier Casasnovas, Hôpital Le Bocage, Dijon; Anne Julian and Guy Laurent, Hôpital Purpan, Toulouse; Pauline Brice and Nathalie Berenger, Hôpital Saint Louis, Paris; Christelle Tychyj-Pinel and Gilles Salles, Centre Hospitalier Lyon Sud, Pierre Benite; Hervé Tilly and Pierre Vera, Centre Henri Becquerel, Rouen; Nicolas Mounier and Gaetano Paone, Hôpital de...

family: Dupuis

full_name: Jehan Dupuis

given: Jehan

family: Berriolo-Riedinger

full_name: Alina Berriolo-Riedinger

given: Alina

family: Julian

full_name: Anne Julian

given: Anne

family: Brice

full_name: Pauline Brice

given: Pauline

family: Tychyj-Pinel

full_name: Christelle Tychyj-Pinel

given: Christelle

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Mounier

full_name: Nicolas Mounier

given: Nicolas

family: Gallamini

full_name: Andrea Gallamini

given: Andrea

family: Feugier

full_name: Pierre Feugier

given: Pierre

family: Soubeyran

full_name: Pierre Soubeyran

family: Colombat

full_name: Philippe Colombat

given: Philippe

family: Laurent

full_name: Guy Laurent

given: Guy

family: Berenger

full_name: Nathalie Berenger

given: Nathalie

family: Casasnovas

full_name: Rene-Olivier Casasnovas

given: Rene-Olivier

family: Vera

full_name: Pierre Vera

family: Paone

full_name: Gaetano Paone

given: Gaetano

family: Xerri

full_name: Luc Xerri

given: Luc

family: Salles

full_name: Gilles Salles

given: Gilles

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Meignan

full_name: Michel Meignan

given: Michel

publisher_group: American Society of Clinical Oncology (ASCO)

title: Impact of [18F]Fluorodeoxyglucose Positron Emission Tomography Response Evaluation in Patients With High–Tumor Burden Follicular Lymphoma Treated With Immunochemotherapy: A Prospective Study From the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS

lead_sponsor: Lymphoma Study Association

location_country: Italy France

location_facility:
Hôpital Henri Mondor
Hôpital Necker
Centre Bergognié
Centre Henri Becquerel
CHU - Limoges
CHRU Lille
CHU Avicenne
CHU Brabois
CHU Purpan
Hôpital Saint-Louis
Ospedale Cuneo
CHU de Dijon
CHU Robert Debré
Hôpital Pitié-Salpêtrière
CHU - Besançon
Institut Gustave Roussy
Clinique Victor Hugo
Centre Paoli-Calmettes
CHU - Nantes
Centre Hospitalier - Lens
CHU Lyon Sud
Hôpital Bretonneau


title: Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone

summary:
This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. The goal is to be able to identify patients who will best respond to the study treatments or experience the fewest associated side effects and improve prognosis, in order to optimize care management in multiple myeloma.

To this end, the study seeks to predict the following parameters in these patients:

The treatment response and occurrence of adverse events linked to a lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide combination.
Progression-free survival and overall survival.

Prediction of the treatment response and the occurrence of adverse effects will be based on:

An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and DNA copy number variations.
An analysis of changes in the tumor's genotype (change in the DNA copy number) and phenotype (altered gene and micro-RNA expression).

Prediction of progression-free survival and overall survival will be based on an analysis of changes in the tumor's genotype and phenotype.

primary_purpose: Other

ReferenceCitation: Miannay B, Minvielle S, Roux O, Drouin P, Avet-Loiseau H, Guérin-Charbonnel C, Gouraud W, Attal M, Facon T, Munshi NC, Moreau P, Campion L, Magrangeas F, Guziolowski C. Logic programming reveals alteration of key transcription factors in multiple myeloma. Sci Rep. 2017 Aug 23;7(1):9257. doi: 10.1038/s41598-017-09378-9.

family: Miannay

full_name: Bertrand Miannay

given: Bertrand

family: Minvielle

full_name: Stéphane Minvielle

given: Stéphane

family: Roux

full_name: Olivier Roux

given: Olivier

family: Drouin

full_name: Pierre Drouin

family: Avet-Loiseau

full_name: Hervé Avet-Loiseau

family: Guérin-Charbonnel

full_name: Catherine Guérin-Charbonnel

given: Catherine

family: Gouraud

full_name: Wilfried Gouraud

given: Wilfried

family: Attal

full_name: Michel Attal

family: Facon

full_name: Thierry Facon

given: Thierry

family: Munshi

full_name: Nikhil C Munshi

given: Nikhil C

family: Moreau

full_name: Philippe Moreau

family: Campion

full_name: Loïc Campion

given: Loïc

family: Magrangeas

full_name: Florence Magrangeas

given: Florence

family: Guziolowski

full_name: Carito Guziolowski

given: Carito

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Scientific Reports

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

location_facility:
Chu Rennes
CHR METZ
CH Blois
Institut Curie
Chu Poitiers
CHRU Lille
René Huguenin
Chu Nantes
CH Mulhouse
CHU Dijon
CHU LYON
CH Côte basque
Chu Grenoble
Ipc Marseille
Chu Tours
CHD Vendée
Chalon sur Saone
Chu Nancy
BORDEAUX
CH Yves Le Foll
LYON SUD
Ch Dunkerque
Centre Antoine LACASSAGNE
Chu Toulouse
CHRU Angers
CH ALBI


title: Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting

acronym: ENTERRA

summary:
The aim of this clinical trial is to assess the symptomatic efficacy and the impact on the utilization of healthcare resources of a treatment by gastric electrical stimulation (ENTERRA ®) in patients with refractory nausea and/or vomiting leading to a nutritional impairment. Eligible patients will be those with refractory symptoms either idiopathic, postsurgical or due to diabetes mellitus. The duration of the study will be 28 months for each patient.

After a run-in period of 4 months during which a prospective assessment of healthcare resources utilization and of the severity of the symptoms will be obtained, patients will be implanted. The follow-up period after implantation of the device will last 24 months in every patients and will be divided in two parts: a) After the first postoperative month during which the device will remained on the "OFF" position, the first phase of the study will be a randomized double-blind cross-over study with 2 periods of 4 months during which the device will be activated or not. After the 9th month of follow up, the trial will be an open trial and the device will be activated in all patients.

During the whole trial, patients will record all types of healthcare resources utilizations (hospitalizations, drug treatments, endoscopic procedures…) while the symptomatic efficacy of the treatment will be assessed by standard questionnaires at the following visits scheduled at 1, 5, 9, 12, 18, 24 months. The glycemic control will be determined at each visit in diabetic patients. A delayed gastric emptying will not be a selection criteria but we have planned to analyze the clinical results of the treatment in taking into account a delayed or normal gastric emptying during the pre-implantation period. Moreover, gastric emptying studies have been scheduled at 5, 9, 12 and 24 months to test the impact of gastric electrical stimulation on gastric emptying.

ReferenceCitation: Gourcerol G, Coffin B, Bonaz B, Hanaire H, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi P, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Ducrotte P, Guerci B; ENTERRA Research Group. Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study. Clin Gastroenterol Hepatol. 2020 Nov 13. pii: S1542-3565(20)31544-5. doi: 10.1016/j.cgh.2020.11.011. [Epub ahead of print]

family: Gourcerol

full_name: Guillaume Gourcerol

given: Guillaume

family: Coffin

full_name: Benoit Coffin

given: Benoit

family: Bonaz

full_name: Bruno Bonaz

given: Bruno

family: Hanaire

full_name: Hélène Hanaire

given: Hélène

family: Bruley Des Varannes

full_name: Stanislas Bruley Des Varannes

given: Stanislas

family: Zerbib

full_name: Frank Zerbib

given: Frank

family: Caiazzo

full_name: Robert Caiazzo

given: Robert

family: Grimaud

full_name: Jean Charles Grimaud

given: Jean Charles

family: Mion

full_name: François Mion

given: François

family: Hadjadj

full_name: Samy Hadjadj

given: Samy

family: Valensi

full_name: Paul Valensi

given: Paul

family: Vuitton

full_name: Lucine Vuitton

given: Lucine

family: Charpentier

full_name: Guillaume Charpentier

family: Ropert

full_name: Alain Ropert

given: Alain

family: Altwegg

full_name: Romain Altwegg

given: Romain

family: Pouderoux

full_name: Philippe Pouderoux

given: Philippe

family: Dorval

full_name: Etienne Dorval

given: Etienne

family: Dapoigny

full_name: Michel Dapoigny

family: Duboc

full_name: Henri Duboc

given: Henri

family: Benhamou

full_name: Pierre Yves Benhamou

given: Pierre Yves

family: Schmidt

full_name: Aurélie Schmidt

given: Aurélie

family: Donnadieu

full_name: Nathalie Donnadieu

given: Nathalie

family: Ducrotte

full_name: Philippe Ducrotte

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Ducrotte P, Coffin B, Bonaz B, Fontaine S, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi PE, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Gourcerol G, Guerci B; ENTERRA Research Group. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. 2020 Feb;158(3):506-514.e2. doi: 10.1053/j.gastro.2019.10.018. Epub 2019 Oct 21.

location_facility:
UH Nancy
UH Tours
UH Lyon
UH Clermont Ferrand
UH Toulouse
UH Rennes
Corbeil Essones Hospital
UH Lille
UH Nantes
UH Nimes
AP-HP Jean Verdier
UH Bordeaux
UH Poitiers
UH Besancon
UH Rouen
UH Montpellier
UH Marseille
UH Grenoble
UH Nice
AP-HP Louis Mourier
UH Strasbourg


title: A Phase II Study Evaluating the Association of Topotecan and Lapatinib in Early Recurrent (Less Than 12 Months)Ovarian or Peritoneal Cancer Patients After First Line of Platinum-Based Chemotherapy

acronym: TOPO-LAPA

summary: The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Paul Papin
Centre René Gauducheau
Centre azuréen de cancérologie
Centre Jean Bernard
Centre Alexis vautrin
Centre Antoine Lacassagne
CHD Les Oudairies
Institut Jean Godinot
Institut CURIE
Institut Claudius regaud
Centre Val d'Aurelle
Centre G-F Leclerc
Centre Paul Strauss
Institut Bergonié
Institut Gustave Roussy
Institut de Cancérologie de la Loire
CHU Jean MINJOZ
Hôpital Diaconesses
Centre François Baclesse
Centre Catherine de Sienne
APHP Hopital TENON


title: A Phase II Study of the Efficacy and Safety of Lenalidomide Combined to Escalating Doses of Chemotherapy in Intermediate-2-or High Risk MDS and AML With Del 5q

acronym: GFM-Chimio-Rev

summary: In this trial, the investigators will test the combination of escalating doses of chemotherapy (starting at relatively low dose) with lenalidomide in intermediate-2-or high risk MDS and AML with del 5 q31. It is hoped that this combined therapy will further increase response rate in intermediate-2-or high risk MDS and AML with del 5 q31, without major toxicity in comparison to historical results obtained with chemotherapy alone in the same subset of patients.

status: Unknown status

ReferenceCitation: Ades L, Prebet T, Stamatoullas A, Recher C, Guieze R, Raffoux E, Bouabdallah K, Hunault M, Wattel E, Stalnikiewicz L, Toma A, Dombret H, Vey N, Sebert M, Gardin C, Chaffaut C, Chevret S, Fenaux P. Lenalidomide combined with intensive chemotherapy in acute myeloid leukemia and higher-risk myelodysplastic syndrome with 5q deletion. Results of a phase II study by the Groupe Francophone Des Myélodysplasies. Haematologica. 2017 Apr;102(4):728-735. doi: 10.3324/haematol.2016.151894. Epub 2016 Dec 29.

family: Ades

full_name: Lionel Ades

given: Lionel

family: Prebet

full_name: Thomas Prebet

given: Thomas

family: Stamatoullas

full_name: Aspasia Stamatoullas

given: Aspasia

family: Recher

full_name: Christian Recher

given: Christian

family: Guieze

full_name: Romain Guieze

family: Raffoux

full_name: Emmanuel Raffoux

given: Emmanuel

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

family: Hunault

full_name: Mathilde Hunault

given: Mathilde

family: Wattel

full_name: Eric Wattel

given: Eric

family: Stalnikiewicz

full_name: Laure Stalnikiewicz

given: Laure

family: Toma

full_name: Andrea Toma

given: Andrea

family: Dombret

full_name: Hervé Dombret

given: Hervé

family: Vey

full_name: Norbert Vey

given: Norbert

family: Sebert

full_name: Marie Sebert

given: Marie

family: Gardin

full_name: Claude Gardin

given: Claude

family: Chaffaut

full_name: Cendrine Chaffaut

given: Cendrine

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Ferrata Storti Foundation (Haematologica)

location_facility: Hopital Purpan Service d'Hématologie Clinique


title: A Pilot, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase IIA Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 (40 and 80 mg Bid) as Adjunctive Therapy to Acetylcholinesterase Inhibitor Over a 3-month Period in Ambulatory Patients Suffering From Mild to Moderate Alzheimer's Disease (EHT 0202/002 Protocol)

summary: The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.

lead_sponsor: Exonhit

location_facility: Purpan-Casselardit Hospital - University of Toulouse


title: Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia : A Prospective Study for a Blood Diagnostic Test in Alzheimer's Disease - (Protocol n° EHTAD/002).

summary: The objective of the study is to define the performance of blood-based signatures for Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and non-demented controls.

primary_purpose: Diagnostic

intervention_type: Device


title: The Efficacy of Minoxidil in Children With Williams-Beuren Syndrome: a Randomized Clinical Trial.

acronym: Williams

summary:
The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a multisystem developmental impairment. This syndrome is caused by a microdeletion in chromosome 7q11.23 that encompasses loss of the elastin locus.

Elastin, which is part of the extracellular matrix, controls proliferation of vascular smooth muscle cells (VSMCs) and stabilizes arterial structure. Loss of elastin gene in WBS patients has been claimed to provide a biological basis for the abnormal elastic fibre properties leading to cardiovascular abnormalities like supravalvular aortic stenosis (SVAS), hypertension, arteriosclerosis and stenosis in more than 50% of WBS children.

These cardiovascular pathologies result in important consequences and neither curative nor preventive medicinal treatments exist at this time. Surgery is needed in more than half cases, while it is often leading to complications.

Minoxidil is a well-known antihypertensive drug used in adults and children. Furthermore, according to animal studies, minoxidil seems to increase arterial elastin content by decreasing elastase activity in these tissues. Other data demonstrate that minoxidil specifically stimulate elastin synthesis.

Working Hypothesis:If insufficient elastin synthesis leads to vascular complications and arterial hypertension in children with WBS, restoration of sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial tension. Therefore, as a pharmacological agent capable to stimulate elastin expression, minoxidil might be a useful drug for the treatment of abnormal elastin metabolism in WBS children.

Objective:To evaluate the efficacy of minoxidil on cardiovascular structure in children with Williams Beuren syndrome.

Methodology: randomized controlled trial on two parallel group (23 patients in each arm) Main criterion:variation of carotid Intima-media thickness (IMT) before and after 12 months of treatment with Minoxidil versus placebo Secondary intermediate criteria of the vascular properties are arterial stiffness, cardiac and renal stenosis, arterial tension.

Total study duration:30 months including a 12 month-recruitment period

ReferenceCitation: Kassai B, Bouyé P, Gilbert-Dussardier B, Godart F, Thambo JB, Rossi M, Cochat P, Chirossel P, Luong S, Serusclat A, Canterino I, Mercier C, Rabilloud M, Pivot C, Pirot F, Ginhoux T, Coopman S, Grenet G, Gueyffier F, Di-Fillippo S, Bertholet-Thomas A. Minoxidil versus placebo in the treatment of arterial wall hypertrophy in children with Williams Beuren Syndrome: a randomized controlled trial. BMC Pediatr. 2019 May 28;19(1):170. doi: 10.1186/s12887-019-1544-1.

apc_source: openAPC

family: Kassai

full_name: Behrouz Kassai

given: Behrouz

family: Bouyé

full_name: Philippe Bouyé

given: Philippe

family: Gilbert-Dussardier

full_name: Brigitte Gilbert-Dussardier

given: Brigitte

family: Godart

full_name: François Godart

given: François

family: Thambo

full_name: Jean-Benoit Thambo

given: Jean-Benoit

family: Rossi

full_name: Massimiliano Rossi

given: Massimiliano

family: Cochat

full_name: Pierre Cochat

family: Chirossel

full_name: Pierre Chirossel

family: Luong

full_name: Stephane Luong

given: Stephane

family: Serusclat

full_name: André Serusclat

given: André

family: Canterino

full_name: Isabelle Canterino

given: Isabelle

family: Mercier

full_name: Catherine Mercier

given: Catherine

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Pivot

full_name: Christine Pivot

given: Christine

family: Pirot

full_name: Fabrice Pirot

given: Fabrice

family: Ginhoux

full_name: Tiphanie Ginhoux

given: Tiphanie

family: Coopman

full_name: Stéphanie Coopman

given: Stéphanie

family: Grenet

full_name: Guillaume Grenet

given: Guillaume

family: Gueyffier

full_name: François Gueyffier

family: Di-Fillippo

full_name: Sylvie Di-Fillippo

family: Bertholet-Thomas

full_name: Aurélia Bertholet-Thomas

given: Aurélia

journal_name: BMC Pediatrics

location_facility: Service de Génétique Médicale, CHU La Milétrie

location_facility: Département de Pédiatrie, Hôpital Femme Mère Enfant

location_facility: Service de Cardiologie Pédiatrique, Hôpital Cardiovasculaire L. Pradel

location_facility: Service des Maladies Cardiovasculaires Infantiles et Congénitales, CHRU Lille

location_facility: Service de Physiologie, Explorations Fonctionnelles, Hôpital Robert Debré

location_facility: Service de Cardiologie Pédiatrique, Hôpital Necker Enfants Malades

location_facility: Unité de Pharmacologie Clinique, Hôpital Robert Debré

location_facility: Service de Néphrologie Pédiatrique, Hôpital Pellegrin, CHU Bordeaux

location_facility: Service de Cardiologie Pédiatrique, CHU Angers

location_facility: Service de Cardiologie - Hôpital des Enfants

location_facility: Service de Cardiologie, Hôpital Saint-André, CHU Bordeaux

location_facility: Service de Néphrologie Pédiatrique, CHRU de Lille

location_facility: Service de Cardiologie Infantile, CHU Nancy

location_facility: Service de Néphrologie Pédiatrique - Hôpital des Enfants, CHU Toulouse

location_facility: Service de Pathologie Cardiaque Congénitale du Fœtus, de l'Enfant et de l'Adulte, Hôpital Haut Lévêque, CHU de Bordeaux

location_facility: Département de Pédiatrie- Service de Cardiologie, CHU Grenoble

location_facility: Service de Génétique Médicale, Hôpital Pellegrin, CHU Bordeaux


title: Randomised Multicentric Phase III Study Comparing Observation Versus Post-surgery Radiotherapy After Complete Exeresis With Margins Greater Than or Equal to 1 cm in Soft Tissues Members Sarcoma.

summary:
Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them.

These rare tumors involve complex multidisciplinary care better in centers having expertise.

Loco-regional therapy strategies have evaluated over time for tumors of members leading to propose more often the combination of a large conservative tumor excision with radiotherapy. Results have been demonstrated equivalent to those of an amputation in terms of local control and survival.

The local recurrence rate for sarcomas of the members of any kind after surgery with or without radiotherapy in the literature varies from 10 to 30%.

The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

location_facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle


ReferenceCitation: Borg C, André T, Mantion G, Boudghène F, Mornex F, Maingon P, Adenis A, Azria D, Piutti M, Morsli O, Bosset JF. Pathological response and safety of two neoadjuvant strategies with bevacizumab in MRI-defined locally advanced T3 resectable rectal cancer: a randomized, noncomparative phase II study. Ann Oncol. 2014 Nov;25(11):2205-2210. doi: 10.1093/annonc/mdu377. Epub 2014 Aug 13.

family: Borg

full_name: C. Borg

given: C.

family: André

full_name: T. André

given: T.

family: Mantion

full_name: G. Mantion

given: G.

family: Boudghène

full_name: F. Boudghène

given: F.

family: Mornex

full_name: F. Mornex

family: Maingon

full_name: P. Maingon

given: P.

family: Adenis

full_name: A. Adenis

given: A.

family: Azria

full_name: D. Azria

given: D.

family: Piutti

full_name: M. Piutti

given: M.

family: Morsli

full_name: O. Morsli

given: O.

family: Bosset

full_name: J.F. Bosset

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

acronym: INOVA

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Polyclinique Du Parc; Centre De Hautes Energies

location_facility: Hopital Saint Louis; Radiotherapie Oncologie

location_facility: Ch Lyon Sud; Radiotherapie Sct Jules Courmont

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Centre Hospitalier Andre Boulloche; Departement D'Oncologie

location_facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

location_facility: Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

location_facility: Centre Val Aurelle Paul Lamarque; Radiotherapie

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

title: Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study

summary: This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).


title: Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Oesophageal Cancer.

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.

ReferenceCitation: Cuer B, Conroy T, Juzyna B, Gourgou S, Mollevi C, Touraine C. Joint modelling with competing risks of dropout for longitudinal analysis of health-related quality of life in cancer clinical trials. Qual Life Res. 2021 Nov 24. doi: 10.1007/s11136-021-03040-8. [Epub ahead of print]

family: Cuer

full_name: Benjamin Cuer

given: Benjamin

family: Conroy

full_name: Thierry Conroy

given: Thierry

family: Juzyna

full_name: Beata Juzyna

given: Beata

family: Gourgou

full_name: Sophie Gourgou

given: Sophie

family: Mollevi

full_name: Caroline Mollevi

given: Caroline

family: Touraine

full_name: Célia Touraine

given: Célia

journal_name: Quality of Life Research

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Cuer B, Mollevi C, Anota A, Charton E, Juzyna B, Conroy T, Touraine C. Handling informative dropout in longitudinal analysis of health-related quality of life: application of three approaches to data from the esophageal cancer clinical trial PRODIGE 5/ACCORD 17. BMC Med Res Methodol. 2020 Sep 3;20(1):223. doi: 10.1186/s12874-020-01104-w.

full_name: B. Cuer

given: B.

full_name: C. Mollevi

family: Anota

full_name: A. Anota

family: Charton

full_name: E. Charton

given: E.

full_name: B. Juzyna

full_name: T. Conroy

full_name: C. Touraine

journal_name: BMC Medical Research Methodology

ReferenceCitation: Conroy T, Galais MP, Raoul JL, Bouché O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, François E, Créhange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Fédération Francophone de Cancérologie Digestive and UNICANCER-GI Group. Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial. Lancet Oncol. 2014 Mar;15(3):305-14. doi: 10.1016/S1470-2045(14)70028-2. Epub 2014 Feb 18. Erratum in: Lancet Oncol. 2014 Dec;15(13):e587. Erratum in: Lancet Oncol. 2014 Dec;15(13):e587.

family: Galais

full_name: Marie-Pierre Galais

given: Marie-Pierre

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospital Regional Universitaire de Limoges


lead_sponsor: Nantes University Hospital

location_facility:
CHU Hôpital Minjoz
CHU Carémeau
CHU Amiens
CHU du Bocage
CH Avignon
CH La Source
CHU Hautepierre
CHU Hôtel Dieu
CH Metz Thionvile
CHU Brabois
CHU Purpan
CHU Michallon
CH Muller
CH Pays d'Aix
CH Louis Pasteur
CHU Robert Debré
CHU Lapeyronie
CHU Dupuytren
CHU Pontchaillou
Institut Paoli Calmette
CHU Bretonneau
Institut de Cancérologie de la Loire
CHU du Haut Lévèque
Hopital Cochin (AP-HP)
Centre Hospitalier de la Côte Basque
CHRU Angers
CHU Morvan
CHU Jean Bernard - La Milétrie

title: Randomized Open Phase III Trial Testing Efficacy of Gemtuzumab Ozogamycin (MYLOTARG) Associated to Intensive Chemotherapy for Patients Aged Between 18-60 Years and Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk

summary: The main objective of the study is to improve outcome of younger patients (between 18-60 years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In this population, in the absence of bone marrow transplantation, event free survival (EFS) is estimated at 35% after three years of follow-up. Adjunction of gemtuzumab ozogamycin (MYLOTARG®) to standard chemotherapy is supposed to increase EFS up to 50% at 3 years. To test this hypothesis, the Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang (GOELAMS ) sponsored by Nantes University Hospital leads this randomized open phase III trial in 29 French centers.

lead_sponsor_type: academique


title: Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis

acronym: CHIC

summary: The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular carcinoma for patients with cirrhosis.

ReferenceCitation: Paisant A, Vilgrain V, Riou J, Oberti F, Sutter O, Laurent V, Rodes A, Guiu B, Cassinotto C, Trillaud H, Bricault I, Michalak S, Bruno O, Ronot M, Aubé C. Comparison of extracellular and hepatobiliary MR contrast agents for the diagnosis of small HCCs. J Hepatol. 2020 May;72(5):937-945. doi: 10.1016/j.jhep.2019.12.011. Epub 2019 Dec 21.

family: Paisant

full_name: Anita Paisant

given: Anita

family: Vilgrain

full_name: Valérie Vilgrain

given: Valérie

family: Riou

full_name: Jérémie Riou

given: Jérémie

family: Oberti

full_name: Frédéric Oberti

given: Frédéric

family: Sutter

full_name: Olivier Sutter

given: Olivier

family: Laurent

full_name: Valérie Laurent

family: Rodes

full_name: Agnès Rodes

given: Agnès

family: Guiu

full_name: Boris Guiu

given: Boris

family: Cassinotto

full_name: Christophe Cassinotto

given: Christophe

family: Trillaud

full_name: Hervé Trillaud

given: Hervé

family: Bricault

full_name: Ivan Bricault

given: Ivan

family: Michalak

full_name: Sophie Michalak

family: Bruno

full_name: Onorina Bruno

given: Onorina

family: Ronot

full_name: Maxime Ronot

given: Maxime

family: Aubé

full_name: Christophe Aubé

journal_name: Journal of Hepatology

ReferenceCitation: Aubé C, Oberti F, Lonjon J, Pageaux G, Seror O, N'Kontchou G, Rode A, Radenne S, Cassinotto C, Vergniol J, Bricault I, Leroy V, Ronot M, Castera L, Michalak S, Esvan M, Vilgrain V; CHIC Group. EASL and AASLD recommendations for the diagnosis of HCC to the test of daily practice. Liver Int. 2017 Oct;37(10):1515-1525. doi: 10.1111/liv.13429. Epub 2017 Apr 26.

name: Département de Radiologie; CHU d'Angers; Université Bretagne Loire; Angers France

name: Laboratoire HIFIH; Université Bretagne Loire, Université d'Angers; Angers France

name: Service de Gastroenterologie et Hépatologie; Université Bretagne Loire, CHU d'Angers; Angers France

name: Département de Radiologie; CHU Saint Eloi; Université de Montpellier; Montpellier France

family: Lonjon

full_name: Julie Lonjon

given: Julie

name: Département d'hépatogastroentérologie; CHU Saint Eloi; Université de Montpellier; Montpellier France

family: Pageaux

full_name: Georges Pageaux

given: Georges

name: Service de Radiologie; Hôpital Jean Verdier; Hôpitaux universitaires Paris-Seine-Saint-Denis; Assistance publique Hôpitaux de Paris; Bondy France

name: Unité mixte de Recherche 1162; Génomique fonctionnelle des Tumeurs solides; Institut National de la Santé et de la Recherche médicale; Paris France

name: Unité de Formation et de Recherche Santé Médecine et Biologie humaine; Université Paris 13; Communauté d'Universités et Etablissements Sorbonne Paris Cité; Paris France

family: Seror

full_name: Olivier Seror

name: Service d'hépato gastroentérologie; Hôpital Jean Verdier; Hôpitaux Universitaires Paris-Seine-Saint-Denis; Assistance publique Hôpitaux de Paris; Bondy France

family: N'Kontchou

full_name: Giséle N'Kontchou

given: Giséle

name: Département de Radiologie; Hôpital de la Croix Rousse, CHU Lyon; Lyon France

name: Service d'hépatologie; Hôpital de la croix rousse; Unité INSERM 1052; CHU Lyon; Lyon France

name: Département d'imagerie diagnostique et interventionnelle; Hôpital Haut-Lévèque; CHU Bordeaux; Pessac France

name: Service Hépato-gastroentérologie; CHU de Bordeaux; Hôpital Haut-Lévêque; Pessac France

name: Département d'imagerie; Radiologie et imagerie médicale, CHU; Grenoble France

name: Laboratory of Techniques for Biomedical Engineering And Complexity Management - Informatics, Mathematics and Applications; Université Grenoble Alpes; Grenoble France

name: Service d'hépato gastroentérologie; University Hospital; Grenoble France

name: Département de Radiologie; Hôpital Beaujon; Hôpitaux Paris Nord Val de Seine (AP-HP); Clichy France

name: Service d'hépatologie; Hôpital Beaujon; Assistance Publique-Hopitaux de Paris; Clichy France

name: Université Paris Diderot; Sorbonne Paris Cité, CRI, U1149; Paris France

name: Département d'anatomopatologie; CHU d'Angers; LUNAM Université; Angers France

name: Assistance Publique - Hôpitaux de Paris; Hôpital européen Georges-Pompidou; Unité d’Épidémiologie et de Recherche Clinique; Paris France

name: INSERM, Centre d’Investigation Clinique 1418; module Épidémiologie Clinique; Paris France

location_facility:
CHU Angers
Hôpital Saint-André
Hôpital Nord
Hôpital E. Herriot
CHU
Hôpital Saint Antoine
Hôpital de la croix rousse
Hôpital Pontchaillou
Hôpital Saint Éloi
hôpital Beaujon
Hôpital Du Bocage
Hôpital Paul Brousse
Hôpital Brabois
Hôpital Hôtel Dieu
Hôpital Haut-Lévèque
hôpital Henri Mondor
Chu
Institut Gustave Roussy
hôpital archet II


title: A Multicentre, Randomized, Open-label Study to Evaluate the Efficacy andSafety of Fondaparinux Versus Low Molecular Weight Heparin(Nadroparin) in Patients Requiring Rigid or Semi-rigid Immobilization for at Least 21 Days and up to 45 Days Because of Isolated Non-surgical Below-Knee Injury

acronym: FONDACAST

summary: The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood clots that migrate to the lungs) in patients with leg injuries below the knee that require a cast or other type of immobilization but not surgery.

primary_purpose: Prevention

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Netherlands
France
Russian Federation
Spain
Germany


lead_sponsor: Cephalon

location_country:
Italy
France
Poland
Ireland
Spain
Germany
United Kingdom

title: A European Multicenter Open-Label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

summary: Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually titrated to an effective dose that provides adequate analgesia and minimizes undesirable effects. To reach the safest effective dose for the individual patient as soon as possible, the dose titration process is critical. The aim of this study, conducted under pragmatic conditions in a large-scale population of cancer patients is to compare the proportion of patients reaching an effective FBT dose after titration starting with either a 100 mcg dose or a 200 mcg dose.


ReferenceCitation: Bertucci F, Fekih M, Autret A, Petit T, Dalenc F, Levy C, Romieu G, Bonneterre J, Ferrero JM, Kerbrat P, Soulie P, Mouret-Reynier MA, Bachelot T, Lerebours F, Eymard JC, Deblock M, Lortholary A, Hardy-Bessard AC, Barthelemy P, Bonnefoi H, Charafe-Jauffret E, Bidard FC, Viens P, Lemonnier J, Pierga JY. Bevacizumab plus neoadjuvant chemotherapy in patients with HER2-negative inflammatory breast cancer (BEVERLY-1): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2016 May;17(5):600-11. doi: 10.1016/S1470-2045(16)00011-5. Epub 2016 Mar 28.

family: Bertucci

full_name: François Bertucci

given: François

family: Fekih

full_name: Mahmoud Fekih

given: Mahmoud

family: Autret

full_name: Aurélie Autret

given: Aurélie

family: Petit

full_name: Thierry Petit

given: Thierry

family: Dalenc

full_name: Florence Dalenc

given: Florence

family: Levy

full_name: Christelle Levy

given: Christelle

family: Romieu

full_name: Gilles Romieu

given: Gilles

family: Bonneterre

full_name: Jacques Bonneterre

given: Jacques

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Kerbrat

full_name: Pierre Kerbrat

given: Pierre

family: Soulie

full_name: Patrick Soulie

given: Patrick

family: Mouret-Reynier

full_name: Marie-Ange Mouret-Reynier

given: Marie-Ange

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Lerebours

full_name: Florence Lerebours

family: Eymard

full_name: Jean-Christophe Eymard

given: Jean-Christophe

family: Deblock

full_name: Mathilde Deblock

given: Mathilde

family: Lortholary

full_name: Alain Lortholary

given: Alain

family: Hardy-Bessard

full_name: Anne-Claire Hardy-Bessard

given: Anne-Claire

family: Barthelemy

full_name: Philippe Barthelemy

given: Philippe

family: Bonnefoi

full_name: Hervé Bonnefoi

family: Charafe-Jauffret

full_name: Emmanuelle Charafe-Jauffret

given: Emmanuelle

family: Bidard

full_name: François-Clément Bidard

given: François-Clément

family: Viens

full_name: Patrice Viens

given: Patrice

family: Lemonnier

full_name: Jérôme Lemonnier

given: Jérôme

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported under the following conditions: the data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_facility: Centre Hospitalier General Andre Boulloche

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

title: Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer

summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.


title: Profile of Hypertensive Patients Aged of 75 Years and Older Seen in General Practitioner According to Their Renal Damage.

acronym: SERENITE

summary: Describe the clinical characteristics of hypertensive patients aged of 75 years and older seen in general practitioner consultation according to their renal damage


title: A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer

summary: The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.

lead_sponsor: Boehringer Ingelheim

location_facility:
1239.2.3303F Institut Gustave Roussy
1239.2.3304C Hôpital Robert Debré
1239.2.3301C Hôpital Saint Antoine
1239.2.3303D Institut Gustave Roussy
1239.2.3302A Hôpital Tenon
1239.2.3301I Hôpital Saint Antoine
1239.2.3301F Hôpital Saint Antoine
1239.2.3301B Hôpital Saint Antoine
1239.2.3304B Hôpital Robert Debré
1239.2.3301J Hôpital Saint Antoine
1239.2.3301D Hôpital Saint Antoine
1239.2.3301A Hôpital Saint Antoine
1239.2.3301G Hôpital Saint Antoine
1239.2.3301H Hôpital Saint Antoine
1239.2.3301E Hôpital Saint Antoine
1239.2.3301K Hôpital Saint Antoine
1239.2.3303A Institut Gustave Roussy
1239.2.3304A Hôpital Robert Debré
1239.2.3305A clinique Saint Jean
1239.2.3305B Cabinet Médical
1239.2.3303B Institut Gustave Roussy
1239.2.3303E Institut Gustave Roussy
1239.2.3302B Hôpital Tenon
1239.2.3303C Institut Gustave Roussy


title: An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreated Brain Metastasis

summary: This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals.

design_allocation: Non-Randomized


title: Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).

acronym: TASTE

summary:
Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.

ReferenceCitation: Wislez M, Barlesi F, Besse B, Mazières J, Merle P, Cadranel J, Audigier-Valette C, Moro-Sibilot D, Gautier-Felizot L, Goupil F, Renault A, Quoix E, Souquet PJ, Madroszyck A, Corre R, Pérol D, Morin F, Zalcman G, Soria JC. Customized adjuvant phase II trial in patients with non-small-cell lung cancer: IFCT-0801 TASTE. J Clin Oncol. 2014 Apr 20;32(12):1256-61. doi: 10.1200/JCO.2013.53.1525. Epub 2014 Mar 17.

name: Marie Wislez and Jacques Cadranel, Hôpital Tenon, Assistance Publique des Hôpitaux de Paris; Franck Morin, Intergroupe Francophone de Cancérologie Thoracique, Paris; Fabrice Barlesi, Aix Marseille University, Assistance Publique des Hôpitaux de Marseille; Anne Madroszyck, Institut Paoli Calmettes, Marseille; Benjamin Besse and Jean-Charles Soria, Institut Gustave Roussy, Villejuif; Julien Mazières, Hôpital Larrey, Toulouse; Patrick Merle, Centre Hospitalier Universitaire (CHU) de Clermont-Ferrand,...

family: Wislez

full_name: Marie Wislez

given: Marie

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Besse

full_name: Benjamin Besse

given: Benjamin

family: Mazières

full_name: Julien Mazières

given: Julien

family: Merle

full_name: Patrick Merle

family: Cadranel

full_name: Jacques Cadranel

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Gautier-Felizot

full_name: Laure Gautier-Felizot

given: Laure

family: Goupil

full_name: François Goupil

given: François

family: Renault

full_name: Aldo Renault

given: Aldo

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Madroszyck

full_name: Anne Madroszyck

given: Anne

family: Corre

full_name: Romain Corre

given: Romain

family: Pérol

full_name: David Pérol

given: David

family: Morin

full_name: Franck Morin

given: Franck

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Customized Adjuvant Phase II Trial in Patients With Non–Small-Cell Lung Cancer: IFCT-0801 TASTE

location_facility: Lyon - Hôpital Louis Pradel (Pneumologie)