title: A Randomized, Open Label, Phase II Trial of Bevacizumab Plus Weekly Paclitaxel Followed by Bevacizumab Monotherapy Maintenance Versus Weekly Paclitaxel Followed by Observation in Patients With Relapsed Ovarian Sex-cord Stromal Tumours

acronym: ALIENOR

summary:
Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood vessels (a process called "angiogenesis"). This can reduce blood flow of the tumor and then decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the tumor from growing.

In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already benefits from a marketing authorization (MMA) for these various types of cancers.

The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is ended.

This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal since this tumors are very well vascularized.

The ALIENOR study aims to explore the interest and the clinical benefit of associating bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords- stromal tumor treated beforehand by platinum chemotherapy

ReferenceCitation: Ray-Coquard I, Harter P, Lorusso D, Dalban C, Vergote I, Fujiwara K, Gladieff L, Lück HJ, Floquet A, Chevalier-Place A, Schnelzer A, Pignata S, Selle F, Sehouli J, Brocard F, Mangili G, Pautier P, De Giorgi U, Provansal M, Heudel PE. Effect of Weekly Paclitaxel With or Without Bevacizumab on Progression-Free Rate Among Patients With Relapsed Ovarian Sex Cord-Stromal Tumors: The ALIENOR/ENGOT-ov7 Randomized Clinical Trial. JAMA Oncol. 2020 Dec 1;6(12):1923-1930. doi: 10.1001/jamaoncol.2020.4574.

name: GINECO and Centre Léon Bérard, University Claude Bernard Lyon 1, Lyon, France

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

name: AGO Study Group and Ev Kliniken Essen-Mitte, Essen, Germany

family: Harter

full_name: Philipp Harter

given: Philipp

name: MITO and Istituto Nazionale Tumori, Milan, Italy

family: Lorusso

full_name: Domenica Lorusso

given: Domenica

name: GINECO and Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France

family: Dalban

full_name: Cécile Dalban

given: Cécile

name: BGOG and University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium

family: Vergote

full_name: Ignace Vergote

given: Ignace

name: GOTIC and Saitama Medical University International Medical Center, Hidaka, Japan

family: Fujiwara

full_name: Keiichi Fujiwara

given: Keiichi

name: GINECO and Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France

family: Gladieff

full_name: Laurence Gladieff

given: Laurence

name: AGO Study Group and Gyneco-Oncological Practice, Hannover, Germany

family: Lück

full_name: Hans-Joachim Lück

given: Hans-Joachim

name: GINECO and Institut Bergonié, Bordeaux, France

family: Floquet

full_name: Anne Floquet

given: Anne

name: GINECO and Centre Oscar Lambret, Lille, France

family: Chevalier-Place

full_name: Annick Chevalier-Place

given: Annick

name: AGO Study Group and Frauenklinik Technical University Munich, Munich, Germany

name: Current, RoMed Klinikum Rosenheim, Rosenheim, Germany

family: Schnelzer

full_name: Andreas Schnelzer

given: Andreas

name: MITO and Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy

family: Pignata

full_name: Sandro Pignata

given: Sandro

name: GINECO and Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France

family: Selle

full_name: Frédéric Selle

name: AGO Study Group and Medical University of Berlin, Charité–CVK, Berlin, Germany

family: Sehouli

full_name: Jalid Sehouli

given: Jalid

name: GINECO and Centre Oncologie de Gentilly, Nancy, France

family: Brocard

full_name: Fabien Brocard

given: Fabien

name: MITO and Ospedale San Raffaele, Milan, Italy

family: Mangili

full_name: Giorgia Mangili

given: Giorgia

name: GINECO and Gustave Roussy, Villejuif, France

family: Pautier

full_name: Patricia Pautier

given: Patricia

name: MITO and Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy

family: De Giorgi

full_name: Ugo De Giorgi

given: Ugo

name: GINECO and Institut Paoli Calmettes, Marseille, France

family: Provansal

full_name: Magali Provansal

given: Magali

name: GINECO and Centre Léon Bérard, Lyon, France

family: Heudel

full_name: Pierre-Etienne Heudel

given: Pierre-Etienne

journal_name: JAMA Oncology

oa_host_type: repository

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: CHU de Poitiers - Hôpital de la Milétrie


title: A Phase II Randomized Multicentre Study Evaluating the Efficacy of Pazopanib+Best Supportive Care (BSC) Versus BSC Alone in Metastatic and/or Locally Advanced Unresectable GIST, Resistant to Imatinib and Sunitinib

acronym: PAZOGIST

summary: The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

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ReferenceCitation: Casali PG, Jost L, Reichardt P, Schlemmer M, Blay JY; ESMO Guidelines Working Group. Gastrointestinal stromal tumors: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008 May;19 Suppl 2:ii35-8. doi: 10.1093/annonc/mdn080.

ReferenceCitation: Demetri GD, Benjamin RS, Blanke CD, Blay JY, Casali P, Choi H, Corless CL, Debiec-Rychter M, DeMatteo RP, Ettinger DS, Fisher GA, Fletcher CD, Gronchi A, Hohenberger P, Hughes M, Joensuu H, Judson I, Le Cesne A, Maki RG, Morse M, Pappo AS, Pisters PW, Raut CP, Reichardt P, Tyler DS, Van den Abbeele AD, von Mehren M, Wayne JD, Zalcberg J; NCCN Task Force. NCCN Task Force report: management of patients with gastrointestinal stromal tumor (GIST)--update of the NCCN clinical practice guidelines. J Natl Compr Canc Netw. 2007 Jul;5 Suppl 2:S1-29; quiz S30. Review. Erratum in: J Natl Compr Canc Netw. 2007 Aug;5(7):xxx.

ReferenceCitation: Reichardt P, Blay JY, Mehren Mv. Towards global consensus in the treatment of gastrointestinal stromal tumor. Expert Rev Anticancer Ther. 2010 Feb;10(2):221-32. doi: 10.1586/era.09.171. Review.

ReferenceCitation: Montemurro M, Schöffski P, Reichardt P, Gelderblom H, Schütte J, Hartmann JT, von Moos R, Seddon B, Joensuu H, Wendtner CM, Weber E, Grünwald V, Roth A, Leyvraz S. Nilotinib in the treatment of advanced gastrointestinal stromal tumours resistant to both imatinib and sunitinib. Eur J Cancer. 2009 Sep;45(13):2293-7. doi: 10.1016/j.ejca.2009.04.030. Epub 2009 May 19.

ReferenceCitation: Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schöffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009 Jul 1;27(19):3126-32. doi: 10.1200/JCO.2008.21.3223. Epub 2009 May 18.

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ReferenceCitation: Rubin BP, Singer S, Tsao C, Duensing A, Lux ML, Ruiz R, Hibbard MK, Chen CJ, Xiao S, Tuveson DA, Demetri GD, Fletcher CD, Fletcher JA. KIT activation is a ubiquitous feature of gastrointestinal stromal tumors. Cancer Res. 2001 Nov 15;61(22):8118-21.

ReferenceCitation: Heinrich MC, Corless CL, Duensing A, McGreevey L, Chen CJ, Joseph N, Singer S, Griffith DJ, Haley A, Town A, Demetri GD, Fletcher CD, Fletcher JA. PDGFRA activating mutations in gastrointestinal stromal tumors. Science. 2003 Jan 31;299(5607):708-10. Epub 2003 Jan 9.

ReferenceCitation: Fletcher CD, Berman JJ, Corless C, Gorstein F, Lasota J, Longley BJ, Miettinen M, O'Leary TJ, Remotti H, Rubin BP, Shmookler B, Sobin LH, Weiss SW. Diagnosis of gastrointestinal stromal tumors: A consensus approach. Hum Pathol. 2002 May;33(5):459-65. Review.

ReferenceCitation: Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13.

ReferenceCitation: Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A, Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004 Sep 25-Oct 1;364(9440):1127-34.

ReferenceCitation: Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008 Feb 1;26(4):626-32. doi: 10.1200/JCO.2007.13.4452.

ReferenceCitation: Blanke CD, Demetri GD, von Mehren M, Heinrich MC, Eisenberg B, Fletcher JA, Corless CL, Fletcher CD, Roberts PJ, Heinz D, Wehre E, Nikolova Z, Joensuu H. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008 Feb 1;26(4):620-5. doi: 10.1200/JCO.2007.13.4403.

ReferenceCitation: Heinrich MC, Maki RG, Corless CL, Antonescu CR, Harlow A, Griffith D, Town A, McKinley A, Ou WB, Fletcher JA, Fletcher CD, Huang X, Cohen DP, Baum CM, Demetri GD. Primary and secondary kinase genotypes correlate with the biological and clinical activity of sunitinib in imatinib-resistant gastrointestinal stromal tumor. J Clin Oncol. 2008 Nov 20;26(33):5352-9. doi: 10.1200/JCO.2007.15.7461. Epub 2008 Oct 27.

ReferenceCitation: Kumar R, Knick VB, Rudolph SK, Johnson JH, Crosby RM, Crouthamel MC, Hopper TM, Miller CG, Harrington LE, Onori JA, Mullin RJ, Gilmer TM, Truesdale AT, Epperly AH, Boloor A, Stafford JA, Luttrell DK, Cheung M. Pharmacokinetic-pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activity. Mol Cancer Ther. 2007 Jul;6(7):2012-21.

ReferenceCitation: Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarbá JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.

ReferenceCitation: Hutson TE, Davis ID, Machiels JP, De Souza PL, Rottey S, Hong BF, Epstein RJ, Baker KL, McCann L, Crofts T, Pandite L, Figlin RA. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2010 Jan 20;28(3):475-80. doi: 10.1200/JCO.2008.21.6994. Epub 2009 Dec 14.

ReferenceType: derived

ReferenceCitation: Mir O, Cropet C, Toulmonde M, Cesne AL, Molimard M, Bompas E, Cassier P, Ray-Coquard I, Rios M, Adenis A, Italiano A, Bouché O, Chauzit E, Duffaud F, Bertucci F, Isambert N, Gautier J, Blay JY, Pérol D; PAZOGIST study group of the French Sarcoma Groupe-Groupe d'Etude des Tumeurs Osseuses (GSF-GETO). Pazopanib plus best supportive care versus best supportive care alone in advanced gastrointestinal stromal tumours resistant to imatinib and sunitinib (PAZOGIST): a randomised, multicentre, open-label phase 2 trial. Lancet Oncol. 2016 May;17(5):632-41. doi: 10.1016/S1470-2045(16)00075-9. Epub 2016 Apr 5.

family: Mir

full_name: Olivier Mir

given: Olivier

sequence: first

family: Cropet

full_name: Claire Cropet

given: Claire

sequence: additional

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Cesne

full_name: Axel Le Cesne

given: Axel Le

family: Molimard

full_name: Mathieu Molimard

given: Mathieu

family: Bompas

full_name: Emmanuelle Bompas

given: Emmanuelle

family: Cassier

full_name: Philippe Cassier

given: Philippe

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Rios

full_name: Maria Rios

given: Maria

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Italiano

full_name: Antoine Italiano

family: Bouché

full_name: Olivier Bouché

family: Chauzit

full_name: Emmanuelle Chauzit

family: Duffaud

full_name: Florence Duffaud

given: Florence

family: Bertucci

full_name: François Bertucci

given: François

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Gautier

full_name: Julien Gautier

given: Julien

location_facility:
Centre Léon Bérard
Centre Alexis Vautrin
Institut de Cancérologie de l'Ouest
Hôpital St Antoine
Centre Oscar Lambret
Hôpital Tenon
CHU de Reims
Centre Georges François Leclerc
Hôpital de la Timone
Institut Paoli Calmette
Institut Cancerologie Neuwirth
Institut Bergonié
Institut Gustave Roussy


title: Identification of the Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor of HR+ Metastatic Breast Cancer in Post-menopausal Women

acronym: SAFIR-TOR

summary: This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit from treatment with everolimus in patients who are eligible for everolimus+exemestane treatment. This trial is not aimed at evaluating a drug activity. Everolimus and exemestane are prescribed within their approved indication as per usual practice and are not part of this trial.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Screening

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: UNICANCER

location_facility: INSTITUT DE CANCEROLOGIE Lucien Neuwirth

location_facility: Institut de Cancérologie de l'Ouest/Rene Gauducheau

location_facility: Institut de Cancérologie de l'Ouest/Paul Papin

location_facility: Institut de Cancerologie de Lorraine Alexis Vautrin

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort in Subjects With Male Stress Urinary Incontinence

summary: The purpose of this study is to monitor the use of Virtue® Male Sling in a real world population and collect medical data on effectiveness and to monitor safety of Virtue® at 12 and 36 months post device implantation in men with post-prostatectomy urinary incontinence.

status: Recruiting

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

ipd_sharing_description: There is not a plan to make IPD available

lead_sponsor: Coloplast A/S

location_country: Italy France

location_facility: Clinique Mutualiste de la Porte de l'Orient

intervention_type: Device


title: A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With Oral Potentially Malignant Lesions (OPML) or Head and Neck Squamous Cell Carcinoma (HNSCC) (IHNPACT UMBRELLA)

acronym: UMBRELLA

summary:
This is a multicenter minimal risk or burden prospective 3-cohort follow-up and monitoring study that aims to collect clinical, socio-psychological, medico-economics data and biospecimens for patients with oral potentially malignant lesions (OPML) or resectable head and neck squamous cell carcinoma (HNSCC) :

Cohort A: OPML patients.
Cohort B (specific design): smokers (adults who have smoked at least 100 cigarettes in their lifetime) motivated to quit - either current smokers (who currently smokes cigarettes every day (daily) or some days (nondaily)) or former smokers (adults who have smoked at least 100 cigarettes in their lifetime, but say they currently do not smoke) who stops smoking within 3 months prior to the diagnosis - with a resectable HNSCC requiring postoperative radiotherapy or chemoradiation.
Cohort C: Patients with resectable HNSCC non-eligible to cohort B.

The primary objective of this study is the identification of biomarkers (predictive of malignant transformation or second primary tumor) and new strategies for prevention and therapy, mainly through extensive genomic, epigenomic and immune characterization of OPML and HNSCC.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Prevention

ReferenceCitation: Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2:CD005084. doi: 10.1002/14651858.CD005084.pub4.

name: School of Dental Sciences; Newcastle University; Newcastle upon Tyne UK

family: Holliday

full_name: Richard Holliday

given: Richard

name: Oral Surgery Department; Birmingham Dental Hospital; Birmingham UK

family: Hong

full_name: Bosun Hong

given: Bosun

name: Population Health Sciences Institute; Newcastle University; Newcastle upon Tyne UK

family: McColl

full_name: Elaine McColl

given: Elaine

name: Nuffield Department of Primary Care Health Sciences; University of Oxford; Oxford UK

family: Livingstone-Banks

full_name: Jonathan Livingstone-Banks

given: Jonathan

family: Preshaw

full_name: Philip M Preshaw

given: Philip M

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Centre Leon Berard

location_facility: CHU de Montpellier, Hôpital Gui De Chauliac

location_facility: Hospices Civils de Lyon, Hôpital Lyon Sud

lead_sponsor_type: academique

status_simplified: Unknown


type: EudraCT Number

title: Phase III Randomized Clinical Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer Considering Two Different Settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)

acronym: CHIPPI

summary: This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone.

lead_sponsor: Centre Oscar Lambret

location_facility:
ICM-Val d'Aurelle
Centre François Baclesse
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Hôpital de Hautepierre
Clinique Mathilde
Centre Jean Perrin
Centre Hospitalier Lyon Sud
Institut de Cancérologie de Lorraine
Institut Paoli Calmettes
Hôpital Jeanne de Flandre
Hôpital Européen Georges Pompidou
Centre Henri Becquerel
Institut Gustave Roussy

intervention_type: Drug


type: Other Identifier

title: Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Low or Intermediate-1 Myelodysplastic Syndrome: A Prospective Multicenter Phase II Study Based on Donor Availability on Behalf of the GFM & SFGM-TC

summary: Comparison of survival in patients with or without a matched donor at 36 months

ReferenceCitation: Robin M, Fenaux P. Which lower risk myelodysplastic syndromes should be treated with allogeneic hematopoietic stem cell transplantation? Leukemia. 2020 Oct;34(10):2552-2560. doi: 10.1038/s41375-020-0967-x. Epub 2020 Jul 13. Review.

family: Robin

full_name: Marie Robin

given: Marie

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

journal_name: Leukemia

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Institut de cancérologie Lucien Neuwirth

intervention_type: Other


title: Gemcitabine-oxaliplatin Plus Rituximab (R-GEMOX) in Refractory/Relapsed Patients With CD 20 Positive Diffuse Large B-cell Lymphoma, Non Eligible for High-dose Chemotherapy Followed by Autotransplantation

summary: The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible for autologous transplantation.

ReferenceCitation: Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42.

ReferenceCitation: Chau I, Webb A, Cunningham D, Hill M, Rao S, Ageli S, Norman A, Gill K, Howard A, Catovsky D. An oxaliplatin-based chemotherapy in patients with relapsed or refractory intermediate and high-grade non-Hodgkin's lymphoma. Br J Haematol. 2001 Dec;115(4):786-92.

ReferenceCitation: Machover D, Delmas-Marsalet B, Misra SC, Gumus Y, Goldschmidt E, Schilf A, Frénoy N, Emile JF, Debuire B, Guettier C, Farrokhi P, Boulefdaoui B, Norol F, Parquet N, Ulusakarya A, Jasmin C. Dexamethasone, high-dose cytarabine, and oxaliplatin (DHAOx) as salvage treatment for patients with initially refractory or relapsed non-Hodgkin's lymphoma. Ann Oncol. 2001 Oct;12(10):1439-43.

ReferenceCitation: Faivre S, Raymond E, Woynarowski JM, Cvitkovic E. Supraadditive effect of 2',2'-difluorodeoxycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines. Cancer Chemother Pharmacol. 1999;44(2):117-23.

ReferenceCitation: Savage DG, Rule SA, Tighe M, Garrett TJ, Oster MW, Lee RT, Ruiz J, Heitjan D, Keohan ML, Flamm M, Johnson SA. Gemcitabine for relapsed or resistant lymphoma. Ann Oncol. 2000 May;11(5):595-7.

ReferenceCitation: Mounier N, El Gnaoui T, Tilly H, Canioni D, Sebban C, Casasnovas RO, Delarue R, Sonet A, Beaussart P, Petrella T, Castaigne S, Bologna S, Salles G, Rahmouni A, Gaulard P, Haioun C. Rituximab plus gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large B-cell lymphoma who are not candidates for high-dose therapy. A phase II Lymphoma Study Association trial. Haematologica. 2013 Nov;98(11):1726-31. doi: 10.3324/haematol.2013.090597. Epub 2013 Jun 10.

family: Mounier

full_name: N. Mounier

given: N.

family: El Gnaoui

full_name: T. El Gnaoui

given: T.

family: Tilly

full_name: H. Tilly

given: H.

family: Canioni

full_name: D. Canioni

given: D.

family: Sebban

full_name: C. Sebban

given: C.

family: Casasnovas

full_name: R.-O. Casasnovas

family: Delarue

full_name: R. Delarue

given: R.

family: Sonet

full_name: A. Sonet

given: A.

family: Beaussart

full_name: P. Beaussart

given: P.

family: Petrella

full_name: T. Petrella

family: Castaigne

full_name: S. Castaigne

given: S.

family: Bologna

full_name: S. Bologna

family: Salles

full_name: G. Salles

given: G.

family: Rahmouni

full_name: A. Rahmouni

family: Gaulard

full_name: P. Gaulard

family: Haioun

full_name: C. Haioun

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: publisher-specific license

license_normalized: publisher-specific

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Lymphoma Study Association

location_facility: Service des Maladies du Sang - CHRU de Lille

location_facility: Service d'Hématologie Clinique - CHU Le Bocage

location_facility: Service D'Hématologie Adulte - Hôpital Necker


title: Phase I Study of Fluvastatin-Celebrex Association for Optico-chiasmatic Low Grade Gliomas and High Grade Gliomas Localized Outside the Brainstem, Relapsed or Refactory, in Children or Young Adults

acronym: FLUVABREX

summary:
Optico-chiasmatic gliomas have therapeutic feature since surgical resection plays a secondary role. Unlike other sites, many of these tumors are not amenable to complete resection either because of anatomical location, and sometimes they only can be biopsied. A substantial number of children will have recurrences following resection or will experience progression following incomplete tumor removal or biopsy.

Celebrex is a Cox-2 inhibitor with anti-angiogenic and anti-tumor properties, while statins are known to increase the sensitivity of gliomas to anti-tumor agents. Their association could be administered for long periods, in the hope of much reduced risk of toxicities.

This is a national, multicentric, interventional, open-label, non-comparative, and non-randomized phase I study evaluating the maximum tolerated dose of the Fluvastatin in combination with fixed-dose of Celebrex.

This project involves 10 SFCE health centers accustomed to phase I / II studies(Société Française de Lutte contre les Cancers et Leucémies de l'Enfant et de l'Adolescent - French Society for the Fight against Cancer and Leukemia in Children and Adolescents).

location_facility: Centre Hospitalier de Bordeaux - Hôpital des Enfants

location_facility: Centre Hospitalier de Nantes - Hôpital Mère enfants

location_facility: Centre Hospitalier de Purpan - Hôpital des Enfants


title: Thoracic Aortic Stent-graft Study for the Treatment of Thoracic Aortic Pathologies - Assessment of the Relay Plus and Relay NBS Plus Stent-graft

summary: Stent treatment of thoracic aortic pathologies, including aneurysms, pseudo-aneurysms, dissections, intramural hematomas, penetrating ulcers and ruptures of the isthmus, seems to provide a likely benefit compared to surgery in terms of surgical mortality and severe morbidity. However, the data concerning the long-term fate of these stents are insufficient. For this reason, the French National Health Authority (HAS) requests a 5-year follow-up in relation to the renewal of insurance reimbursement for these stent-grafts. Therefore, this long-term observational study has been set up.

lead_sponsor: Vascutek Ltd.

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel - HCL

location_facility: Hôpitaux Universitaires de Strasbourg - NHC


title: Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus

summary: Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Cláudio N, Dalet A, Gatti E, Pierre P. Mapping the crossroads of immune activation and cellular stress response pathways. EMBO J. 2013 May 2;32(9):1214-24. doi: 10.1038/emboj.2013.80. Epub 2013 Apr 12. Review.

family: Cláudio

full_name: Nuno Cláudio

given: Nuno

family: Dalet

full_name: Alexandre Dalet

given: Alexandre

family: Gatti

full_name: Evelina Gatti

given: Evelina

family: Pierre

full_name: Philippe Pierre

given: Philippe

bso_classification: Biology (fond.)

journal_name: The EMBO Journal

ReferenceCitation: Clavarino G, Cláudio N, Couderc T, Dalet A, Judith D, Camosseto V, Schmidt EK, Wenger T, Lecuit M, Gatti E, Pierre P. Induction of GADD34 is necessary for dsRNA-dependent interferon-β production and participates in the control of Chikungunya virus infection. PLoS Pathog. 2012;8(5):e1002708. doi: 10.1371/journal.ppat.1002708. Epub 2012 May 17.

family: Clavarino

full_name: Giovanna Clavarino

given: Giovanna

family: Couderc

full_name: Thérèse Couderc

given: Thérèse

family: Judith

full_name: Delphine Judith

given: Delphine

family: Camosseto

full_name: Voahirana Camosseto

given: Voahirana

family: Schmidt

full_name: Enrico K. Schmidt

given: Enrico K.

family: Wenger

full_name: Till Wenger

given: Till

family: Lecuit

full_name: Marc Lecuit

given: Marc

currency_apc_doaj: USD

journal_name: PLoS Pathogens

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

title: Induction of GADD34 Is Necessary for dsRNA-Dependent Interferon-β Production and Participates in the Control of Chikungunya Virus Infection

ReferenceCitation: Clavarino G, Cláudio N, Dalet A, Terawaki S, Couderc T, Chasson L, Ceppi M, Schmidt EK, Wenger T, Lecuit M, Gatti E, Pierre P. Protein phosphatase 1 subunit Ppp1r15a/GADD34 regulates cytokine production in polyinosinic:polycytidylic acid-stimulated dendritic cells. Proc Natl Acad Sci U S A. 2012 Feb 21;109(8):3006-11. doi: 10.1073/pnas.1104491109. Epub 2012 Feb 6.

journal_name: Proceedings of the National Academy of Sciences

ReferenceCitation: Costedoat-Chalumeau N, Galicier L, Aumaître O, Francès C, Le Guern V, Lioté F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin du LT, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacré K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Tanguy ML, Hulot JS, Lechat P, Musset L, Amoura Z, Piette JC; Group PLUS. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Ann Rheum Dis. 2013 Nov;72(11):1786-92. doi: 10.1136/annrheumdis-2012-202322. Epub 2012 Nov 10.

ReferenceCitation: Niewold TB, Clark DN, Salloum R, Poole BD. Interferon alpha in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:948364. doi: 10.1155/2010/948364. Epub 2010 Jun 29. Review.

name: Section of Rheumatology and Gwen Knapp Center for Lupus and Immunology Research, The University of Chicago, Chicago, IL 60637, USA

name: Department of Microbiology and Molecular Biology, Brigham Young University, Provo, UT 84602, USA

journal_name: Journal of Biomedicine and Biotechnology

title: Interferon Alpha in Systemic Lupus Erythematosus

ReferenceCitation: Novoa I, Zeng H, Harding HP, Ron D. Feedback inhibition of the unfolded protein response by GADD34-mediated dephosphorylation of eIF2alpha. J Cell Biol. 2001 May 28;153(5):1011-22.

ReferenceCitation: Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.

name: Johns Hopkins University School of Medicine; Baltimore Maryland

name: New York University Langone Medical Center; New York New York

name: Hospital Universitário Pedro Ernesto-Universidade do Estado do Rio de Janeiro; Rio de Janeiro Brazil

name: University of Santo Tomas Hospital; Manila Philippines

name: Human Genome Sciences, Inc.; Rockville Maryland

name: on behalf of the BLISS-52 and BLISS-76 Study Groups

title: Baseline Predictors of Systemic Lupus Erythematosus Flares: Data From the Combined Placebo Groups in the Phase III Belimumab Trials

ReferenceCitation: Rönnelid J, Tejde A, Mathsson L, Nilsson-Ekdahl K, Nilsson B. Immune complexes from SLE sera induce IL10 production from normal peripheral blood mononuclear cells by an FcgammaRII dependent mechanism: implications for a possible vicious cycle maintaining B cell hyperactivity in SLE. Ann Rheum Dis. 2003 Jan;62(1):37-42.

ReferenceCitation: Wang S, Kaufman RJ. The impact of the unfolded protein response on human disease. J Cell Biol. 2012 Jun 25;197(7):857-67. doi: 10.1083/jcb.201110131. Review.

name: Degenerative Disease Research Program, Neuroscience, Aging, and Stem Cell Research Center, Sanford Burnham Medical Research Institute, La Jolla, CA 92037

ReferenceCitation: Yap DY, Lai KN. The role of cytokines in the pathogenesis of systemic lupus erythematosus - from bench to bedside. Nephrology (Carlton). 2013 Apr;18(4):243-55. doi: 10.1111/nep.12047. Review.

name: Division of Nephrology; Department of Medicine; Queen Mary Hospital, University of Hong Kong; Hong Kong SAR

ipd_sharing_description: No data will be be shared with non associated investigator till publication. Possibility to share after publication, through formol requirement adressed to Grenoble hospital administration (AccueilRecherche@chu-grenoble.fr)

location_facility: groupement hospitalier mutualiste de Grenoble


title: Clinical Evaluation of Kaname Cobalt-Chromium Coronary Stent System in the Treatment of Patients With Coronary Artery Disease

acronym: KARE

summary: The purpose of this study is to assess whether the new Kaname coronary stent is safe and effective for the treatment of patients with coronary artery disease.

lead_sponsor: Terumo Europe N.V.

location_country: Italy Serbia France Spain Germany

location_facility: Hopital d'Instructions des Armées du Val de Grace

location_facility: Klinikum des Johannes Gutenberg Universität

location_facility: Institute for Cardiovascular Disease Dedinje

location_facility: Hopital Cardiovasculaire et Pneumologie Louis Pradel

status_simplified: Completed


title: Multicentre, Randomised, Controlled, Open-label Study Comparing the Efficacy and Safety of Doxorubicin Transdrug™ to Best Standard of Care in Patients With Advanced Hepatocellular Carcinoma. ReLive Study.

acronym: ReLive

summary:
The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma (HCC) after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis and with good liver functions are eligible. Only those who can not benefit from treatment for which efficacy is demonstrated are eligible.

These patients are usually proposed either best standard of care (BSC) or participation to clinical trials. Patients eligible for the RELIVE study will receive either DT at 20 mg/m2 or DT at 30 mg/m2 or the BSC.

ReferenceCitation: Merle P, Blanc JF, Phelip JM, Pelletier G, Bronowicki JP, Touchefeu Y, Pageaux G, Gerolami R, Habersetzer F, Nguyen-Khac E, Casadei-Gardini A, Borbath I, Tran A, Wege H, Saad AS, Colombo M, Abergel A, Richou C, Waked I, Yee NS, Molé A, Attali P, Le Boulicaut J, Vasseur B; RELIVE Investigators. Doxorubicin-loaded nanoparticles for patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE): a phase 3 randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Jun;4(6):454-465. doi: 10.1016/S2468-1253(19)30040-8. Epub 2019 Apr 4. Erratum in: Lancet Gastroenterol Hepatol. 2019 Jul;4(7):e6. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):e1.

family: Merle

full_name: Philippe Merle

family: Blanc

full_name: Jean-Frederic Blanc

given: Jean-Frederic

family: Phelip

full_name: Jean-Marc Phelip

given: Jean-Marc

family: Pelletier

full_name: Gilles Pelletier

given: Gilles

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

family: Touchefeu

full_name: Yann Touchefeu

given: Yann

family: Pageaux

full_name: Georges Pageaux

given: Georges

family: Gerolami

full_name: René Gerolami

given: René

family: Habersetzer

full_name: François Habersetzer

given: François

family: Nguyen-Khac

full_name: Eric Nguyen-Khac

given: Eric

family: Casadei-Gardini

full_name: Andrea Casadei-Gardini

given: Andrea

family: Borbath

full_name: Ivan Borbath

given: Ivan

family: Tran

full_name: Albert Tran

given: Albert

family: Wege

full_name: Henning Wege

given: Henning

family: Saad

full_name: Amr Shafik Saad

given: Amr Shafik

family: Colombo

full_name: Massimo Colombo

given: Massimo

family: Abergel

full_name: Armand Abergel

given: Armand

family: Richou

full_name: Carine Richou

given: Carine

family: Waked

full_name: Imam Waked

given: Imam

family: Yee

full_name: Nelson S Yee

given: Nelson S

family: Molé

full_name: Audrey Molé

given: Audrey

family: Attali

full_name: Pierre Attali

given: Pierre

family: Le Boulicaut

full_name: Julie Le Boulicaut

journal_name: The Lancet Gastroenterology & Hepatology

location_country:
Italy
Austria
Lebanon
Germany
France
Hungary
Belgium
Egypt
Spain
Turkey
United States

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet

location_facility: Szegedi Tudományegyetem Onkoterápiás Klinika

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital General Universario Gregorio Maranon

location_facility: Irccs Centro Di Riferimento Oncologico (Cro)

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Klinikum rechts der Isar der TU Munchen II

location_facility: Medical Oncology department /Ain Shams University Hospitals

location_facility: Egyesített Szent István és Szent László Kórház - Rendelőintézet

location_facility: Semmelweis Egyetem Radiológiai és Onkoterápiás Klinika

location_facility: Hospital General Universitario de Alicante

location_facility: National hepatology and tropical medicine research institute

location_facility: National Liver Institute / Menoufyia University

location_facility: Oncology Department, Medical Research Institute, Alexandria University

location_facility: Medical Oncology department /Mansoura University Hospitals

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Clinical Research Center/ Alexandria university hospital

location_facility: Ausl 12 Livorno Ospedale Unico della Versilia

location_facility: IRST Istituto Romagnolo Ricerca e Cura dei Tumori


title: Anesthésie Totale Intraveineuse en " Boucle d'Asservissement " guidée Par l'Index Bispectral : Effet de l'Adjonction de Protoxyde d'Azote (Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia)

summary: The main objective of the study is to analyze the influence of nitrous oxide on propofol and remifentanil requirements.

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

ReferenceCitation: Karalapillai D, Leslie K, Umranikar A, Bjorksten AR. Nitrous oxide and anesthetic requirement for loss of response to command during propofol anesthesia. Anesth Analg. 2006 Apr;102(4):1088-93.

ReferenceCitation: Liu N, Le Guen M, Boichut N, Genty A, Hérail T, Schmartz D, Khefif G, Landais A, Bussac JJ, Charmeau A, Baars J, Rehberg B, Tricoche S, Chazot T, Sessler DI, Fischler M. Nitrous oxide does not produce a clinically important sparing effect during closed-loop delivered propofol-remifentanil anaesthesia guided by the bispectral index: a randomized multicentre study. Br J Anaesth. 2014 May;112(5):842-51. doi: 10.1093/bja/aet479. Epub 2014 Jan 31.

family: Liu

full_name: N. Liu

given: N.

family: Le Guen

full_name: M. Le Guen

given: M.

family: Boichut

full_name: N. Boichut

family: Genty

full_name: A. Genty

given: A.

family: Hérail

full_name: T. Hérail

given: T.

family: Schmartz

full_name: D. Schmartz

given: D.

family: Khefif

full_name: G. Khefif

given: G.

family: Landais

full_name: A. Landais

family: Bussac

full_name: J.J. Bussac

family: Charmeau

full_name: A. Charmeau

family: Baars

full_name: J. Baars

given: J.

family: Rehberg

full_name: B. Rehberg

given: B.

family: Tricoche

full_name: S. Tricoche

given: S.

family: Chazot

full_name: T. Chazot

family: Sessler

full_name: D.I. Sessler

family: Fischler

full_name: M. Fischler

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Nitrous oxide does not produce a clinically important sparing effect during closed-loop delivered propofol–remifentanil anaesthesia guided by the bispectral index: a randomized multicentre study

lead_sponsor: Hopital Foch

location_country: Germany Belgium France

location_facility: Centre Hospitalier Territorial Gaston Bourret


title: Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon

acronym: Lesion SSL

summary:
There are a few studies regarding Sessile Serrated Lesions (SSL). They are recently identified as precancerous lesions. Yet, digestive tract serrated lesions would be part of a new colic carcinogenesis way : the serrated tumor way. Evolution from polyp to cancer would be faster than through the usual adenoma to cancer way. It would be then responsible of a lot of "missed" lesions or interval cancer. The missed SSL rate is estimated at between 27% and 59%.

Current diagnosis methods show weakness to identify those SSL. In order to improve their detection, the investigators dispose of several coloration techniques. Indigo carmine chromoendoscopy enhance neoplastic lesion detection as part of the hereditary rectal carcinoma screening. NBI electronic coloration, which is faster and easier has not shown any efficacy on the adenoma detection rate, except for patients with Lynch syndrome.

The objective is to better describe the SSL endoscopic semiology (detection and characterization) and to establish standards for the endoscopic techniques in order to improve the colonoscopy diagnosis quality. The investigators propose to evaluate 2 fundamental endoscopic techniques (Narrow Band Imaging (NBI) and indigo carmine), widely used for other indications, in comparison with the White Light technique (WLI).

Therefore, the investigators propose a prospective, observational, multicentric cohort study in order to 1) define SSL endoscopic various aspects 2) establish which technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) is the best to diagnose SSL, namely detection and characterization 3) evaluate the multifocal dimension rate for those lesions at ascending colon level.

The diagnosis impact is immediate, and could allow to consider an update for boh endoscopic NICE and Kudo Pit Pattern classification, and good practice guidances for colonoscopic diagnosis. Better SSL detectability thus their systematic resection could have a long term effect in reducing both colon cancer rate and interval cancer

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier Villefranche sur Saône, Service d'Hépato-gastroentérologie, Plateux d'Ouilly Gleize

location_facility: Centre Hospitalier Saint JOSEPH Saint Luc, Service d'hépato-gastroentérologie, 20 quai Claude Bernard

location_facility: Hospices Civils de Lyon, Hôpital Lyon Sud, Service d'hépato-gastroentérologie, Chemin Grand Revoyet

location_facility: Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'hépato-gastroentérologie, 103 Grande-Rue de la Croix Rousse

location_facility: Hôpital Estaing, CHU Clermont Ferrand, NHE Service d'Hépato-gastroentérologie, 1 place Lucie Aubrac

location_facility: Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval


title: Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.

summary: The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

status: Unknown status

lead_sponsor: Hopital Antoine Beclere

location_facility:
Centre Hospitalier Paul Ardier
CH Chambery
Chu Nancy
CH Rouen
CH Dunkerque
CHU Pellegrin
Hopital Diaconesses Croix Saint Simon
CH Rennes
Hopital Saint Andre
Hopital Antoine Beclere
CH Caremeau
Hôtel Dieu
Centre Hospitalier Universitaire
CHU Amiens


type: Registry Identifier

title: Phase III Trial Testing the Benefit of Intensity-modulated Radiotherapy With Weekly Replanifications Versus Intensity Modulated Radiotherapy With Only One Planification in Locally Advanced Oropharynx Carcinoma for Decreasing Xerostomia

acronym: ARTIX

summary: The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.

lead_sponsor: Center Eugene Marquis

location_facility:
Centre Léon Bérard
Centre Eugene Marquis
CRLCC Henri Becquerel
CRLCC Oscar Lambret
Clinique Claude Bernard
CHU de la Milétrie
CRLCC Baclesse
Centre Paul Strauss
CHU Tours
Clinique Pasteur - Saint Esprit
CRLCC Antoine Lacassagne

intervention_type: Radiation


title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy

summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.

ReferenceCitation: Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Friedlander M, Baldoni A, Park-Simon TW, Tamura K, Sonke GS, Lisyanskaya A, Kim JH, Filho EA, Milenkova T, Lowe ES, Rowe P, Vergote I, Pujade-Lauraine E; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):620-631. doi: 10.1016/S1470-2045(21)00073-5. Epub 2021 Mar 18.

family: Poveda

full_name: Andrés Poveda

given: Andrés

family: Floquet

full_name: Anne Floquet

given: Anne

family: Ledermann

full_name: Jonathan A Ledermann

given: Jonathan A

family: Asher

full_name: Rebecca Asher

given: Rebecca

family: Penson

full_name: Richard T Penson

given: Richard T

family: Oza

full_name: Amit M Oza

given: Amit M

family: Korach

full_name: Jacob Korach

given: Jacob

family: Huzarski

full_name: Tomasz Huzarski

given: Tomasz

family: Pignata

full_name: Sandro Pignata

given: Sandro

family: Friedlander

full_name: Michael Friedlander

given: Michael

family: Baldoni

full_name: Alessandra Baldoni

given: Alessandra

family: Park-Simon

full_name: Tjoung-Won Park-Simon

given: Tjoung-Won

family: Tamura

full_name: Kenji Tamura

given: Kenji

family: Sonke

full_name: Gabe S Sonke

given: Gabe S

family: Lisyanskaya

full_name: Alla Lisyanskaya

given: Alla

family: Kim

full_name: Jae-Hoon Kim

given: Jae-Hoon

family: Filho

full_name: Elias Abdo Filho

given: Elias Abdo

family: Milenkova

full_name: Tsveta Milenkova

given: Tsveta

family: Lowe

full_name: Elizabeth S Lowe

given: Elizabeth S

family: Rowe

full_name: Phil Rowe

given: Phil

family: Vergote

full_name: Ignace Vergote

given: Ignace

family: Pujade-Lauraine

full_name: Eric Pujade-Lauraine

given: Eric

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

ReferenceCitation: Tjokrowidjaja A, Lee CK, Friedlander M, Gebski V, Gladieff L, Ledermann J, Penson R, Oza A, Korach J, Huzarski T, Manso L, Pisano C, Asher R, Lord SJ, Kim SI, Lee JY, Colombo N, Park-Simon TW, Fujiwara K, Sonke G, Vergote I, Kim JW, Pujade-Lauraine E. Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy. Eur J Cancer. 2020 Nov;139:59-67. doi: 10.1016/j.ejca.2020.08.021. Epub 2020 Sep 23.

ReferenceCitation: Friedlander M, Gebski V, Gibbs E, Davies L, Bloomfield R, Hilpert F, Wenzel LB, Eek D, Rodrigues M, Clamp A, Penson RT, Provencher D, Korach J, Huzarski T, Vidal L, Salutari V, Scott C, Nicoletto MO, Tamura K, Espinoza D, Joly F, Pujade-Lauraine E. Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. Lancet Oncol. 2018 Aug;19(8):1126-1134. doi: 10.1016/S1470-2045(18)30343-7. Epub 2018 Jul 17.

ReferenceCitation: Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2. Epub 2017 Jul 25. Erratum in: Lancet Oncol. 2017 Sep;18(9):e510.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Italy
United States
Brazil
Netherlands
Spain
Germany
France
Japan
Poland
Israel
Belgium
Australia
Russian Federation
China
Canada
United Kingdom
Korea, Republic of

location_facility: First affiliated hospital college of XianJiaotong University

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Cancer Research UK and UCL Cancer Trials Centre

location_facility: The Tumour Hospital of Harbin Medical University

location_facility: City Hospital Birmingham Cancer Trials Team

location_facility: Barcelona,H.de la Sta.Creu i S.Pau,Oncología

location_facility: Istituto Regina Elena-Polo Oncologico Ifo

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alagre

location_facility: Winthrop Gynecologic Oncology Associates

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: The Tumor Hospital affiliated to China Medical Science Insti

location_facility: Saitama Medical University International Medical Center

location_facility: Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH

location_facility: Royal Marsden Hospital and Institute of Cancer Research

location_facility: Centrum Onkologii Instytut im Marii Sklodowskiej-Curie

location_facility: West China Hospital Affiliated to Sichuan University

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Azienda Ospedaliera Policlinico Di Modena

location_facility: St.Petersburg City Oncology Dispensary, Dept. Gynecology

location_facility: Women's Hospital, Zhejaing University School of Medicine

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: Klinikum rechts der Isar der Technischen Universität

location_facility: Chemotherapy Department, Russian Cancer Research Centre

location_facility: Niigata University Medical and Dental Hospital

location_facility: Shanghai Cancer Hospital of Fudan University

location_facility: Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie


title: Phase 2, Open-Label Study Evaluating Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B-Non Hodgkin Lymphoma (B-NHL) Who Are Ineligible to Autologous Stem Cell Transplantation

summary: This is a phase 2, open-label, multicenter study evaluating axicabtagene ciloleucel (axi-cel) as a 2nd line therapy in patients with Relapsed/Refractory aggressive B-NHL who are ineligible to receive Autologous Stem Cell Transplantation but eligible to receive CAR T-cell therapy.

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility:
Hôpital Saint Antoine
CHU Clermont Ferrand - Hôpital Estaing
CHU de Rennes - Hôpital de Pontchaillou
APHP - Hôpital Saint Louis
CH Liège
Hôpital Claude Huriez
Hopital La Pitié Salpétriere
Centre Hospitalier Lyon Sud
Institut de Cancérologie Gustave Roussy
APHP - Hôpital Henri Mondor
IUCT Oncopole
CHU de Nantes - Hôtel Dieu
Hôpital Saint Eloi
CHU Brabois
CHU de Bordeaux - Hôpital Haut Lévêque
CHU de Dijon - Hôpital le Bocage


title: Feasibility of New Biological and Histological Samples at Progression for Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

acronym: GFPC-REBIOP

summary:
Feasibility of new biological and histological samples at progression in patients with advanced or metastatic Non Small Cell Lung Cancer (NSCLC).

A recent paper from Professor Sequist and coll. has depicted the resistance mechanisms as Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. Re-biopsies showed in 14% of cases the transition between NSCLC to Small Cells Lung Cancer (SCLC). In 3 patients, resistance mechanisms have disappeared and they became again sensitive to Tyrosine Kinase Inhibitors (TKIs). It is mandatory to have a better description to natural history of the disease. This study will be conducted by the French Group of Pneumology-Oncology (Groupe Français de Pneumo Cancérologie (GFPC)) up to 100 patients during 18 Months. Each center will have to define if re-biopsies are possible or not and explain why not.

primary_purpose: Basic Science

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Hospital du Cluzeau
Centre François Baclesse
Hospital Saint Antoine
Site 06
Site 20
Centre Hospitalier du Morvan
Site 04
Centre Hospitalier Universitaire
Site 25


title: High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: Paediatric Arteriopathy Steroid Aspirin (PASTA) Project. A Multicentre Randomized Trial.

acronym: PASTA

summary:
Arterial ischemic stroke (AIS) is a devastating condition, affecting 1.6-5/100,000 children/year. Although their outcome is different, children with stroke do not recover better than adults, with at least 2/3 suffering long term sequels such as developmental (motor, global intellectual, language...) and behavioral disabilities, epilepsy, and low adaptative and academic skills...

Stenotic cerebral arteriopathy is identified as AIS etiology in 60-80% of previously healthy children and the course of this arteriopathy is the strongest predictor of recurrent events. 30-40% of these children have a focal unilateral cerebral arteriopathy (FCA). Childhood FCA is suspected to be an inflammatory vessel wall pathology triggered by varicella and other (viral) infections. As recurrences occur for the great majority in the first 6 months after the index event, aspirin 5 mg/kg/day is recommended for at least 18 months to 2 years.

As there is a rational for using immunomodulatory drugs at the acute stage of FCA, immunotherapies are currently used by neuropaediatricians in AIS, mainly as steroids for children with stenosing arteriopathies. However, due to weak evidences, the literature cannot either encourage or discourage this practice.

The long term course of children with FCA is only approach to date by retrospective studies and controversies about outcome remain (for example, the recurrence risk on antithrombotic treatment varies notably from quasi zero to 25%). And finally, it is shown in childhood stroke, as well as in the global field of longstanding impairment, that parental and medical points of view do not match consistently. Longitudinal studies are needed to deserve this familial approach.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Angers
APHP - Hôpital Necker-Enfants malades
CHU Lyon - Hôpital Femme Mère Enfant
Chu Saint-Etienne
APHP - Hôpital Bicêtre


title: Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)

acronym: ENDOFERT

summary: The ENDOFERT Study is an open, multicenter, randomized, parallel-group, controlled trial. This study includes patients presenting colorectal DIE and infertility. Patients will be randomized in two parallel-groups; one group underwent complete surgery of colorectal DIE prior to ART and the other group underwent ART alone (ratio 1:1)

lead_sponsor: University Hospital, Lille

location_facility:
AP-HP, Hôpital Tenon
CHU
Hôpital Jeanne de Flandres, CHRU


title: Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study

acronym: PEPsy

summary: Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.

location_facility:
Chu Le Vinatier
Chu Grenoble
HÔPITAL Edouard Herriot
Chu Saint Etienne
Chu Clermont-Ferrand


title: Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

acronym: AMPAMAVIR

summary: Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. At the present time, no recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP) procedures. The main objective of this prospective multicentric cohort study is to evaluate the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP, (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the correlation between HPV and male infertility and (4) the correlation between HPV and success rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV vaccination policy.

location_facility:
CHU de SAINT-ETIENNE
Hôpital BICHAT
CHU de CLERMONT-FERRAND
CHU de BORDEAUX
Hôpital Jean VERDIER


title: Search for Predictive Markers of Efficacy of Epoetin Beta (NEORECORMON) in the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Chemotherapy or Myelodysplastic Syndrome

acronym: EPO

summary: Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.

lead_sponsor: Rennes University Hospital

location_facility:
Rennes University Hospital
Saint-Malo Hospital
Yves Le Foll Hospital
Laval Hospital
Bretagne Atlantic Hospital


title: Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients

acronym: HEMIMARCHE

summary: The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months.Following the initial screening, subjects will be randomized into two groups: one who continues attending two physical therapy sessions per week for two months, or the other one who stops physical therapy sessions for two months. Before and after those two months, a 3 days recording will be made using an ambulatory system called TRIDENT.

primary_purpose: Supportive Care

location_facility: Groupe hospitalier Pellegrin CHU Bordeaux

location_facility: Institut Régional de médecine physique et de Réadaptation

location_facility: Centre Régional de Réeducation et de Réadaptation Fonctionnelle

intervention_type: Behavioral


title: Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor

summary:
The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen.

The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.

lead_sponsor: University Hospital, Angers

location_facility:
UH of Lyon
UH of Angers
UH of Montpellier
UH of Rennes
UH of Besancon


title: Optimal Control of Liver Metastases With Intravenous Cetuximab and Hepatic Artery Infusion of Three-drug Chemotherapy in Patients With Liver-only Metastases From Colorectal Cancer. A European Multicenter Phase II Trial

acronym: OPTILIV

summary: The primary objective of the study is to increase by 15% the complete macroscopic resection rate of predominantly liver metastases from metastatic colorectal cancer through combining systemic cetuximab and hepatic artery infusion of three-drug chemotherapy (irinotecan, oxaliplatin and 5-fluorouracil).

ReferenceCitation: Bouchahda M, Boige V, Smith D, Karaboué A, Ducreux M, Hebbar M, Lepère C, Focan C, Guimbaud R, Innominato P, Awad S, Carvalho C, Tumolo S, Truant S, De Baere T, Castaing D, Rougier P, Morère JF, Taieb J, Adam R, Lévi F; ARTBC International. Early tumour response as a survival predictor in previously- treated patients receiving triplet hepatic artery infusion and intravenous cetuximab for unresectable liver metastases from wild-type KRAS colorectal cancer. Eur J Cancer. 2016 Nov;68:163-172. doi: 10.1016/j.ejca.2016.09.011. Epub 2016 Oct 18.

family: Bouchahda

full_name: Mohamed Bouchahda

given: Mohamed

family: Boige

full_name: Valérie Boige

given: Valérie

family: Smith

full_name: Denis Smith

given: Denis

family: Karaboué

full_name: Abdoulaye Karaboué

given: Abdoulaye

family: Ducreux

full_name: Michel Ducreux

given: Michel

family: Hebbar

full_name: Mohamed Hebbar

family: Lepère

full_name: Céline Lepère

given: Céline

family: Focan

full_name: Christian Focan

given: Christian

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

family: Innominato

full_name: Pasquale Innominato

given: Pasquale

family: Awad

full_name: Sameh Awad

given: Sameh

family: Carvalho

full_name: Carlos Carvalho

given: Carlos

family: Tumolo

full_name: Salvatore Tumolo

given: Salvatore

family: Truant

full_name: Stephanie Truant

given: Stephanie

family: De Baere

full_name: Thierry De Baere

given: Thierry

family: Castaing

full_name: Denis Castaing

family: Rougier

full_name: Philippe Rougier

given: Philippe

family: Morère

full_name: Jean-François Morère

given: Jean-François

family: Taieb

full_name: Julien Taieb

given: Julien

family: Adam

full_name: René Adam

given: René

family: Lévi

full_name: Francis Lévi

given: Francis

journal_name: European Journal of Cancer

repository_institution: University of Warwick - Warwick Research Archive Portal

ReferenceCitation: Lévi FA, Boige V, Hebbar M, Smith D, Lepère C, Focan C, Karaboué A, Guimbaud R, Carvalho C, Tumolo S, Innominato P, Ajavon Y, Truant S, Castaing D, De Baere T, Kunstlinger F, Bouchahda M, Afshar M, Rougier P, Adam R, Ducreux M; Association Internationale pour Recherche sur Temps Biologique et Chronothérapie (ARTBC International). Conversion to resection of liver metastases from colorectal cancer with hepatic artery infusion of combined chemotherapy and systemic cetuximab in multicenter trial OPTILIV. Ann Oncol. 2016 Feb;27(2):267-74. doi: 10.1093/annonc/mdv548. Epub 2015 Nov 16.

lead_sponsor: Association pour la Recherche sur le Temps Biologique et la Chronothérapie

location_facility: Chronotherapy Unit, Medical Oncology Department, Paul Brousse Hospital

location_facility: Azienda Ospedaliera S.Maria Degli Angeli


title: Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Romidepsin CHOP (Ro-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

summary: Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by a Response Adjudication Committee (RAC).

location_country:
Italy
Spain
France
Singapore
Belgium
Portugal
Germany
Korea, Republic of

location_facility: CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

location_facility: Charité Medical School Campus Virchow-Klinikum

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: UniversitätsKrebszentrum Göttingen - G-CCC

location_facility: Centre Hospitalier de Versailles - André Mignot

location_facility: Hospital Universitario Dr. Peset de Valencia

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Hospital Universitario Central de Asturias

location_facility: ICO - Institut Català d'Oncologia - Hospital Doctor Josep Trueta

location_facility: Institut d'Hématologie de Basse-Normandie

location_facility: Azienda Ospedaliera universitaria Careggi

location_facility: Istituto di Ematologia "Saragnoli" Policlinico San'Orsola-Malpighi, Bologna

location_facility: Charité Medical School Campus Benjamin Franklin

location_facility: Universitätsklinikum Carl Gustav Carus der TU Dresden

location_facility: Universitätklinikum Freiburg Klinik für Innere medizin I

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo


title: French Biological Observatory on Lung Cancer in Never Smokers

acronym: BioCAST

summary: Lung cancer in non-smokers (LCINS) is an increasing public health problem. The BioCAST (IFCT-1002) study, promoted by Intergroupe Francophone de Cancérologie Thoracique (IFCT), focuses on this entity. It is a national, multicentric, prospective epidemiological study. Main objective is to describe the clinical and molecular epidemiology of LCINS in a large French cohort composed by cases newly diagnosed in participating centres (around to 1000 patients expected). The clinical component of the study is based on collecting data directly from the patient through a standardized questionnaire during a telephone interview with a health professional. The biologic component includes a blood sample collection. A large genomic-wide association study and an epigenetic study are also planned. BioCAST hopes to provide concrete answers to clinicians and patients questions about this new and frequent entity.

ReferenceCitation: Couraud S, Labonne S, Missy P, Morin F, Tran Q, Deroy A, Milleron B, Blanché H, Zalcman G, Souquet PJ; les membres du Groupe de travail " non-fumeurs de l'IFCT ". [Lung cancer in never smokers: a French national cohort (BioCAST/IFCT-1002)]. Rev Mal Respir. 2013 Sep;30(7):576-83. doi: 10.1016/j.rmr.2013.03.006. Epub 2013 May 18. French.

ReferenceCitation: Couraud S, Debieuvre D, Moreau L, Dumont P, Margery J, Quoix E, Duvert B, Cellerin L, Baize N, Taviot B, Coudurier M, Cadranel J, Missy P, Morin F, Mornex JF, Zalcman G, Souquet PJ; BioCAST/IFCT-1002 study investigators. No impact of passive smoke on the somatic profile of lung cancers in never-smokers. Eur Respir J. 2015 May;45(5):1415-25. doi: 10.1183/09031936.00097314. Epub 2015 Mar 5.

family: Couraud

full_name: Sébastien Couraud

given: Sébastien

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Moreau

full_name: Lionel Moreau

given: Lionel

family: Dumont

full_name: Patrick Dumont

given: Patrick

family: Margery

full_name: Jacques Margery

given: Jacques

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Duvert

full_name: Bernard Duvert

given: Bernard

family: Cellerin

full_name: Laurent Cellerin

given: Laurent

family: Baize

full_name: Nathalie Baize

given: Nathalie

family: Taviot

full_name: Bruno Taviot

given: Bruno

family: Coudurier

full_name: Marie Coudurier

given: Marie

family: Cadranel

full_name: Jacques Cadranel

family: Missy

full_name: Pascale Missy

given: Pascale

family: Morin

full_name: Franck Morin

given: Franck

family: Mornex

full_name: Jean-François Mornex

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

journal_name: European Respiratory Journal

evidence: open (via free pdf)

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: Couraud S, Souquet PJ, Paris C, Dô P, Doubre H, Pichon E, Dixmier A, Monnet I, Etienne-Mastroianni B, Vincent M, Trédaniel J, Perrichon M, Foucher P, Coudert B, Moro-Sibilot D, Dansin E, Labonne S, Missy P, Morin F, Blanché H, Zalcman G; French Cooperative Intergroup IFCT. BioCAST/IFCT-1002: epidemiological and molecular features of lung cancer in never-smokers. Eur Respir J. 2015 May;45(5):1403-14. doi: 10.1183/09031936.00097214. Epub 2015 Feb 5.

family: Paris

ReferenceCitation: Couraud S, Vaca-Paniagua F, Villar S, Oliver J, Schuster T, Blanché H, Girard N, Trédaniel J, Guilleminault L, Gervais R, Prim N, Vincent M, Margery J, Larivé S, Foucher P, Duvert B, Vallee M, Le Calvez-Kelm F, McKay J, Missy P, Morin F, Zalcman G, Olivier M, Souquet PJ; BioCAST/IFCT-1002 investigators. Noninvasive diagnosis of actionable mutations by deep sequencing of circulating free DNA in lung cancer from never-smokers: a proof-of-concept study from BioCAST/IFCT-1002. Clin Cancer Res. 2014 Sep 1;20(17):4613-24. doi: 10.1158/1078-0432.CCR-13-3063. Epub 2014 Jul 10.

publisher: American Association for Cancer Research (AACR)

title: Noninvasive Diagnosis of Actionable Mutations by Deep Sequencing of Circulating Free DNA in Lung Cancer from Never-Smokers: A Proof-of-Concept Study from BioCAST/IFCT-1002

ReferenceCitation: Paris C, Do P, Mastroianni B, Dixmier A, Dumont P, Pichon E, Chouaid C, Coudert B, Foucher P, Fraboulet S, Locatelli-Sanchez M, Baize N, Dansin E, Moreau L, Vincent M, Missy P, Morin F, Moro-Sibilot D, Couraud S; BioCAST/IFCT-1002 study investigators; to the BioCAST/IFCT- 1002 study. Association between lung cancer somatic mutations and occupational exposure in never-smokers. Eur Respir J. 2017 Oct 26;50(4). pii: 1700716. doi: 10.1183/13993003.00716-2017. Print 2017 Oct.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

location_facility: Hôpitaux du Léman - Pneumologie et Maladies Infectieuses


title: Open, Non Controlled, Multicenter, Firs-in-human Study for the Evaluation of the Safety, Pharmacokinetics and Preliminary Antitumor Activity of GM102 in Patients With Advanced Pretreated Gynecological Cancer

summary: First in human study, assessing the safety profile, the pharmacokinetics and preliminary antitumor activity of GM102, a new compound (a monoclonal antibody), in patients with previously treated gynecological cancers bearing the AMHRII (anti-mullerian Hormone Receptor II) receptor. The primary objective of the study is to determine the GM102 recommended dose.

ReferenceCitation: Prat M, Le Naour A, Coulson K, Lemée F, Leray H, Jacquemin G, Rahabi MC, Lemaitre L, Authier H, Ferron G, Barret JM, Martinez A, Ayyoub M, Delord JP, Gladieff L, Tabah-Fisch I, Prost JF, Couderc B, Coste A. Circulating CD14(high) CD16(low) intermediate blood monocytes as a biomarker of ascites immune status and ovarian cancer progression. J Immunother Cancer. 2020 Jun;8(1). pii: e000472. doi: 10.1136/jitc-2019-000472.

family: Prat

full_name: Mélissa Prat

given: Mélissa

family: Le Naour

full_name: Augustin Le Naour

given: Augustin

family: Coulson

full_name: Kimberley Coulson

given: Kimberley

family: Lemée

full_name: Fanny Lemée

given: Fanny

family: Leray

full_name: Hélène Leray

given: Hélène

family: Jacquemin

full_name: Godefroy Jacquemin

given: Godefroy

family: Rahabi

full_name: Mouna Chirine Rahabi

given: Mouna Chirine

family: Lemaitre

full_name: Léa Lemaitre

given: Léa

family: Authier

full_name: Hélène Authier

family: Ferron

full_name: Gwenaël Ferron

given: Gwenaël

family: Barret

full_name: Jean-Marc Barret

given: Jean-Marc

family: Martinez

full_name: Alejandra Martinez

given: Alejandra

family: Ayyoub

full_name: Maha Ayyoub

given: Maha

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Gladieff

full_name: Laurence Gladieff

given: Laurence

family: Tabah-Fisch

full_name: Isabelle Tabah-Fisch

given: Isabelle

family: Prost

full_name: Jean-François Prost

given: Jean-François

family: Couderc

full_name: Bettina Couderc

given: Bettina

family: Coste

full_name: Agnès Coste

given: Agnès

journal_name: Journal for ImmunoTherapy of Cancer

license: cc-by-nc

license_normalized: cc-by-nc

title: Circulating CD14highCD16lowintermediate blood monocytes as a biomarker of ascites immune status and ovarian cancer progression

location_facility: Institut Universitaire Cancer Toulouse - Oncopole


title: Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms

summary: The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. The study will satisfy the requirements of the French National Authority for Health (Haute Autorité de santé) and the data collected will be used for reimbursement renewal.

location_facility: Centre Hospitalier Universitaire - Hopital Michallon

location_facility: Centre Hospitalier Universitaire - Hopital Civil

location_facility: Centre Hospitalalier Universitaire - Hopital Brabois


title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase 3 Study to Compare Efficacy and Safety of Masitinib 6 mg/kg/Day in Combination With Bortezomib and Dexamethasone to Placebo in Combination With Bortezomib and Dexamethasone in the Treatment of Patients With Relapsing Multiple Myeloma Who Received One Previous Therapy

summary: The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethasone to placebo in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.

lead_sponsor: AB Science

location_country:
United States
France

location_facility: Froedtert & Medical College of Wisconsin-CLCC


title: Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma

acronym: ART-ORL

summary:
The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat).

This study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy .

The number of patients required in this study is: 300:

Number of patients treated with tomotherapy: 120
Number of patients treated with dynamic arctherapy RapidArc: 120
Number of patients treated with dynamic arctherapy Vmat: 60

This is a prospective; multicentric and non randomized study.

ReferenceCitation: Bibault JE, Dussart S, Pommier P, Morelle M, Huguet M, Boisselier P, Coche-Dequeant B, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Servagi Vernat S, Perrier L, Giraud P. Clinical Outcomes of Several IMRT Techniques for Patients With Head and Neck Cancer: A Propensity Score-Weighted Analysis. Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):929-937. doi: 10.1016/j.ijrobp.2017.06.2456. Epub 2017 Jun 27.

family: Bibault

full_name: Jean-Emmanuel Bibault

given: Jean-Emmanuel

family: Dussart

full_name: Sophie Dussart

given: Sophie

family: Pommier

full_name: Pascal Pommier

given: Pascal

family: Morelle

full_name: Magali Morelle

given: Magali

family: Huguet

full_name: Marius Huguet

given: Marius

family: Boisselier

full_name: Pierre Boisselier

given: Pierre

family: Coche-Dequeant

full_name: Bernard Coche-Dequeant

given: Bernard

family: Alfonsi

full_name: Marc Alfonsi

given: Marc

family: Bardet

full_name: Etienne Bardet

given: Etienne

family: Rives

full_name: Michel Rives

given: Michel

family: Calugaru

full_name: Valentin Calugaru

given: Valentin

family: Chajon

full_name: Enrique Chajon

given: Enrique

family: Noel

full_name: Georges Noel

given: Georges

family: Mecellem

full_name: Hinda Mecellem

given: Hinda

family: Servagi Vernat

full_name: Stephanie Servagi Vernat

given: Stephanie

family: Perrier

full_name: Lionel Perrier

given: Lionel

family: Giraud

full_name: Philippe Giraud

given: Philippe

journal_name: International Journal of Radiation Oncology*Biology*Physics

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Clinical Outcomes of Several IMRT Techniques for Patients With Head and Neck Cancer: A Propensity Score–Weighted Analysis

ReferenceCitation: Bibault JE, Morelle M, Perrier L, Pommier P, Boisselier P, Coche-Dequéant B, Gallocher O, Alfonsi M, Bardet É, Rives M, Calugaru V, Chajon E, Noël G, Mecellem H, Pérol D, Dussart S, Giraud P. Toxicity and efficacy of cetuximab associated with several modalities of IMRT for locally advanced head and neck cancer. Cancer Radiother. 2016 Jul;20(5):357-61. doi: 10.1016/j.canrad.2016.05.009. Epub 2016 Jun 23.

full_name: J.-E. Bibault

full_name: M. Morelle

given: M.

full_name: L. Perrier

given: L.

location_facility:
Centre Eugène Marquis
Hôpital Eurppéen Geoges POMPIDOU
Centre Léon Bérard
Institut BERGONIE
Centre Alexis Vautrin
Centre Val d'Aurelle
Centre Oscar Lambret
Centre Privé de Radiothérapie de Metz
Centre René GAUDUCHEAU
Institut Claudius Regaud
Intitut Curie
Institut Sainte Catherine
Centre Paul STRAUSS
Groupe Oncorad Garonne


title: Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES STUDY)

acronym: EFIRTES

summary:
The present study was designed to assess the efficacy of infliximab in a 2-period study :

An initial period with comparison of infliximab versus placebo and allowing the determination of the primary criteria
Then an extension period in which the 2 arms will receive infliximab (in the placebo group : 5 perfusions and in the experimental group 3 supplemental perfusions). Finally, the 2 groups will receive 5 injections of infliximab There is little evidence in the literature of when and how infliximab should be administered in sarcoidosis. We hypothesized, from our personal experience in 30 cases (18 of which were reported in a retrospective trial (14), that infliximab would have a very quick activity. So it appeared reasonable to evaluate the primary criterion at 6 weeks after initiation of the treatment.

ipd_sharing: Yes

ipd_sharing_description:
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: GH la Pitié Salpêtrière. Service de Médecine interne

location_facility: Hopital Claude Huriez- service de Médecine Interne

location_facility: Hopital de la Timone- service de Médecine Internne

location_facility: Hopital Henri Mondor- service de Médecine Interne

location_facility: Hopital de la Croix Rousse- service de Médecine Interne

location_facility: CHU Hotel Dieu - service de Médecine Interne

location_facility: Nouvel Hopital Civil- service de Médecine Interne

location_facility: Hopital Avicenne - service de pnaumologie


title: Effect of an Early Therapeutic Permutation on the Tumoral Control of Patients Receiving in First Line a Specific Inhibitor of Tyrosin Kinase of EGFR (Erlotinib) or a Taxan-based Chemotherapy for the Treatment of Not Resecable Adenocarcinoma With Bronchiolo-alveolar.

summary: To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.

ReferenceCitation: Wislez M, Gounant V, Cadranel J. [Bronchioloalveolar carcinoma]. Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S70-5. Review. French.

ReferenceCitation: Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77.

ReferenceCitation: Cadranel J, Gervais R, Merle P, Moro-Sibilot D, Westeel V, Bigay-Game L, Quoix E, Friard S, Barlesi F, Lethrosne C, Moreau L, Monnet I, Salaun M, Oliviero G, Souquet PJ, Antoine M, Langlais A, Morin F, Wislez M, Zalcman G; Intergroupe Francophone de Cancérologie Thoracique (IFCT). Erlotinib versus carboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504. Eur Respir J. 2015 Nov;46(5):1440-50. doi: 10.1183/13993003.02358-2014. Epub 2015 Sep 17.

family: Cadranel

full_name: Jacques Cadranel

given: Jacques

family: Gervais

full_name: Radj Gervais

given: Radj

family: Merle

full_name: Patrick Merle

given: Patrick

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Bigay-Game

full_name: Laurence Bigay-Game

given: Laurence

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Friard

full_name: Sylvie Friard

given: Sylvie

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Lethrosne

full_name: Claire Lethrosne

given: Claire

family: Moreau

full_name: Lionel Moreau

family: Monnet

full_name: Isabelle Monnet

given: Isabelle

family: Salaun

full_name: Mathieu Salaun

given: Mathieu

family: Oliviero

full_name: Gérard Oliviero

given: Gérard

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Antoine

full_name: Martine Antoine

given: Martine

family: Langlais

full_name: Alexandra Langlais

given: Alexandra

family: Morin

full_name: Franck Morin

given: Franck

family: Wislez

full_name: Marie Wislez

given: Marie

family: Zalcman

full_name: Gérard Zalcman

title: Erlotinibversuscarboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504

location_facility: APHP - CHU Avicenne - Oncologie Medicale


title: Pacemaker Remote Electrogram Monitoring Study (PREMS)

acronym: PREMS

summary:
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect anomalies that may deserve a clinical action.

PREMS is a non-interventional, prospective, and multicenter study. The primary objective is to assess the added clinical value of periodic IEGMs, based on the rate of patients with a rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring (HM) and non detectable so obvious on the other parameter set offered for the remote follow-up.

lead_sponsor: Biotronik SE & Co. KG

location_facility:
Polyclinique du Parc
Clinique Bon Secours
Hôpital Privé Paul d'Egine
Hôpital Sainte Musse CHI
CH Léon Binet
CH d'Annecy
CH de Bastia
Polyclinique Saint Laurent
Polyclinique Sevigné
Clinique Saint Vincent
CH de Blois
CHG de Longjumeau
CH de Roanne
CH d'Aurillac
Clinique Clairval
CH de Valence
Cabinet de cardiologie
CH Pierre Oudot
CH de Nevers
Clinique de la Marche
CH de Niort
CH André Mignot
CHG Villefranche
Clinique Axium
CH Val d'Ariège
HPOP
Clinique des Dômes
Clinique de l'Anjou
CH de Castres
Clinique Belledonne
Hôpitaux du Léman
CH d'Antibes
HIA Saint Anne
Clinique de Saint Georges de Didonnes
CH Paul Morel
CH de Douarnenez
CH de Chartres
CHU Hôpital Charles Nicolle
CH Annonay
CH de Chambéry
CH de Saint Malo
CH des Broussailles
CH St Luc St Joseph
Polyclinique Nord Aquitaine
Cabinet Descartes
Clinique du Mousseau
CH Montbrison
Cabinet de Cardiologie


title: Comparison of Fecal Microbiota Between Patients With Early and Late Crohn's Disease and Relationship With Different Genetic and Serological Profiles

acronym: COMeBACk

summary:
The cause of CD could be different according to age at onset of CD symptoms. Indeed we know that some very young patients at CD diagnosis have particular genetic variants as abnormalities of the IL10R that are regarded as quite monogenic disease. In the other way, the microbiota also undergoes substantial changes at the extremes of life, in infants and older people and the ramifications of which are very few being explored. The comparison of microbiota by principal component analysis and genetic profile of patients with CD beginning at the extremes of life could help us to better known physiopathology of CD according to age and provide arguments that CD beginning at the extremes of life could be different diseases.

The aim of the study is to ascertain through population-based study the hypothesis that gut microbiota is different between paediatric-onset and elderly-onset CD patients in relation with genetic and environmental mechanisms. The results will provide a better knowledge of the etiopathogenic ways in CD and propose a personalized therapeutic care based on age at CD onset (i.e. according to the gut bacteria involved).

location_facility: Lille University Hospital & EPIMAD Registry

intervention_type: Biological


title: A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

acronym: NEORAD

summary:
Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma

An open-label, exploratory, single-arm, multicenter trial.

Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to nephrectomy.

Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Fôpital d'Instruction des Amées du Val de Grâce

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Hôpital Européen Georges Pompidou - Service d'oncologie médicale


title: A Double-blind Randomized Non-inferiority Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery: Effects on Acute Postoperative Pain.

acronym: ER-One

summary: The block (ESP or PVB) will be performed preoperatively in the recovery room under standard monitoring. After setting a peripheral venous access, patient will be installed on lateral decubitus position on the opposite side of the block.

lead_sponsor: Institut Curie

location_facility:
Institut Claudius Régaud UICT
Centre Jean Perrin
Institut de Cancérologie de Lorraine
Institut Curie
AP-HP Hôpital Tenon


title: A Phase Ib Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma

acronym: RADIOSARP

summary: A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable soft-tissue sarcoma.

ReferenceCitation: Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22. Review.

name: Radiation Oncology University of Cincinnati and Cincinnati Children's Hospital  Cincinnati Ohio

family: Vatner

full_name: Ralph Vatner

given: Ralph

name: Neurosurgery Northwestern University  Chicago Illinois

family: James

full_name: Charles D. James

given: Charles D.

name: Radiation Oncology Northwestern University  Chicago Illinois

family: Sathiaseelan

full_name: Vythialingam Sathiaseelan

given: Vythialingam

name: Greehey Children's Cancer Research Institute University of Texas  San Antonio Texas

family: Bondra

full_name: Kathryn M. Bondra

given: Kathryn M.

family: Kalapurakal

full_name: John A. Kalapurakal

given: John A.

family: Houghton

full_name: Peter J. Houghton

given: Peter J.

journal_name: Pediatric Blood & Cancer

title: Radiation therapy and molecular‐targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges

lead_sponsor: Institut Bergonié

location_facility:
Centre Léon Bérard
Institut du Cancer de Montpellier
Centre Oscar Lambret
Institut Claudius Regaud - IUCT
Institut Bergonié


title: Masitinib in Combination With FOLFIRI Versus Masitinib Alone, Versus Best Supportive Care, in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

summary: A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer

location_country:
France
Czechia
Russian Federation
Spain
United Kingdom

location_facility: Hammersmith Hospital Imperial College Healthcare Nhs Trust


title: An Open-labelled, International, Multicenter, Dose Escalating, Phase I/II Study of SPC2996,an LNA Antisense Molecule Against Bcl-2, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia

summary: The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL)

lead_sponsor: Santaris Pharma A/S

location_country:
Denmark
United States
United Kingdom
France

location_facility: Service d'HématologieCentre Hospitalier Lyon-Syd

location_facility: Holden Comprehensive Cancer Center, Univ. of Iowa

location_facility: MRC Toxicology Unit, University of Leicester


title: Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial

acronym: ACROHNEM

summary: This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.

ReferenceCitation: Foligné B, Plé C, Titécat M, Dendooven A, Pagny A, Daniel C, Singer E, Pottier M, Bertin B, Neut C, Deplanque D, Dubuquoy L, Desreumaux P, Capron M, Standaert A. Contribution of the Gut Microbiota in P28GST-Mediated Anti-Inflammatory Effects: Experimental and Clinical Insights. Cells. 2019 Jun 12;8(6). pii: E577. doi: 10.3390/cells8060577.

apc_source: openAPC

family: Foligné

full_name: Benoît Foligné

given: Benoît

family: Plé

full_name: Coline Plé

given: Coline

family: Titécat

full_name: Marie Titécat

family: Dendooven

full_name: Arnaud Dendooven

given: Arnaud

family: Pagny

full_name: Aurélien Pagny

given: Aurélien

family: Daniel

full_name: Catherine Daniel

given: Catherine

family: Singer

full_name: Elisabeth Singer

given: Elisabeth

family: Pottier

full_name: Muriel Pottier

given: Muriel

family: Bertin

full_name: Benjamin Bertin

given: Benjamin

family: Neut

full_name: Christel Neut

given: Christel

family: Deplanque

full_name: Dominique Deplanque

given: Dominique

family: Dubuquoy

full_name: Laurent Dubuquoy

given: Laurent

family: Desreumaux

full_name: Pierre Desreumaux

given: Pierre

family: Capron

full_name: Monique Capron

given: Monique

family: Standaert

full_name: Annie Standaert

given: Annie

currency_apc_doaj: CHF

journal_name: Cells

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
pdfs.semanticscholar.org

location_facility:
Centre Hospitalier de Boulogne
Centre Hospitalier,
CHRU, Hôpital Claude Huriez
Centre Hospitalier Dunkerque
Centre hospitalier