title: Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking

acronym: HYCOREMA

summary: The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care

primary_purpose: Supportive Care

ReferenceCitation: Lemoine L, Adam V, Galus X, Siles P, Coulon A, Grenier-Desforges J, Orabona J, Kergastel I, Wagner P, Salleron J, Tosti P, Huin-Schohn C, Merlin JL, Etienne R, Henrot P. Conversational hypnosis versus standard of care to reduce anxiety in patients undergoing marker placement under radiographic control prior to breast cancer surgery: A randomized, multicenter trial. Front Psychol. 2022 Nov 22;13:971232. doi: 10.3389/fpsyg.2022.971232. eCollection 2022.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
APHM La Timone
CHRU de Brest
Centre Léon Bérard
CH Bastia
Institut de Cancerologie de Lorraine
Centre Paul Strauss
Chu Bordeaux-Pellegrin

appel_a_projets: PHRIP

region: Grand Est

nom_etablissement: INSTITUT DE CANCEROLOGIE DE LORRAINE

acronyme: HYCOREMA

titre: Essai randomisé comparant l'apport de l'hypnose conversationnelle versus une prise en charge standard sur l'anxiété des patientes lors d'un repérage mammaire préopératoire en échographie

discipline_principale: radiologie

nom_porteur: HENROT

prenom_porteur: Philippe


title: Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

acronym: SCOLEVOL

summary: The hypothesis of this study is that progressive AIS is characterized by a disorder of orthostatic postural control. The analysis and the treatment of posturographic signal on computerized integrate force plates, coupled to clinical and radiographic examinations, could highlight predictive and reliable factors at the moment of diagnosis. Thus, it could help the clinician in his therapeutic approach, based on the postural control improvement (individualized prescription in kinesitherapy, better adaptation to orthopedic treatments by corset). This method is non-invasive, without side effects, fast and achievable in routine care at the moment of the diagnosis of AIS.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Lille Catholic University

collaborators: Ecole des hautes études d'ingénieur (HEI)

location_facility: Centre de MPR pour enfants de Bois Larris

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: GCS GHICL DES HOPITAUX DE L'ICL

type_etablissement: GCS

acronyme: SCOLEVOL

titre: Recherche de facteurs prédictifs d'évolutivité de la Scoliose Idiopathique de l'Adolescent (SIA)

discipline_principale: autre

nom_porteur: CATANZARITI

prenom_porteur: Jean-François


type: Other Identifier

title: MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis

acronym: MICROPRUNG

summary:
Hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest cells in myenteric and submucosal plexi of the bowel wall. The consequence is the absence of parasympathetic control of the distal bowel from the anal sphincter to various levels. The most common type of Hirschsprung disease alters the rectosigmoid (80%). The incidence is around 1/5000 live births. This anomaly requires a surgical ablation of the aganglionic segment.

Regardless of the surgical complications, patients with Hirschsprung disease are exposed to the risk of Hirschsprung Associated EnteroColitis (HAEC). This variable risk, 4-54%, is responsible to a major part of Hirschsprung disease morbimortality. Its onset is more frequent during the first two years of life and then decrease with age.

Its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that involves microbiota, intestinal barrier, immune system and enteric nervous system. This breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be responsible of Crohn's disease onset. Some studies emphasize the role of microbiota in the pathogenesis of HAEC, but the techniques or the methodology with small numbers of patients limit any conclusion or clinical use.

The study hypothesizes microbiota is a major factor in HAEC onset and in their functional bowel problems. Considering HAEC is more frequent the first two years, it's thought that intestinal microbiota changes with time in those patients. This project is innovative because it will use high throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.

Multicentre transversal study.

This study has the potential to significantly modify clinical practice for Hirschsprung disease patients: a better care for HAEC and functional troubles thanks to a better understanding of their microbiota, targetted antibiotic treatment for HAEC, prophylactic treatment of patients at high risk of HAEC.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Arnaud AP, Cousin I, Schmitt F, Petit T, Parmentier B, Levard G, Podevin G, Guinot A, DeNapoli S, Hervieux E, Flaum V, De Vries P, Randuineau G, David-Le Gall S, Buffet-Bataillon S, Boudry G. Different Fecal Microbiota in Hirschsprung's Patients With and Without Associated Enterocolitis. Front Microbiol. 2022 Jun 30;13:904758. doi: 10.3389/fmicb.2022.904758. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ipd_sharing_description: Case Report Form

lead_sponsor: Rennes University Hospital

location_facility:
Nantes University Hospital
Tours University Hospital
Angers University Hospital
Poitiers University Hospital
Brest University Hospital
Caen Univeristy Hospital
Rennes University Hospital

intervention_type: Other

status_simplified: Completed


title: Study of Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Correlation With Clinical and Radiological Evolution

acronym: PHRC-TVC

summary:
Cerebral venous thrombosis is considered as a rare type of stroke with an annual incidence of 3 to 4 per million people. It occurs generally in young patients (mean age of occurrence = 40 years) and principally in young females (75%) generally in pregnancy or oral contraceptive use situations.

The onset may be acute (less than 2 days), subacute (between 2 and 30 days) or chronic (more than 30 days). The clinical presentation is highly variable and includes patients with only a mild headache, others with focal neurological deficits and a few with a dramatic syndrome and a coma. Moreover the evolution can be very different with unpredictable outcome: more often it is favorable with a low mortality rate, but in some cases it can be a worse course. The aim of this study is to evaluate the correlation of some biological markers: thrombin generation test and D-Dimers (marker of fibrin generation and degradation) with the type of onset or the wide spectrum of clinical presentations or the different modes of evolution.

All patients over 16 years ago may be included in the program when CVT diagnosis is proved by magnetic resonance angiography (MRA). For each included patient, there are four blood assays: the first just at the time of diagnosis and before the beginning of treatment, the second before the beginning of the oral anticoagulant treatment. The third assay is done in the third month at the time of a MRA. The last assay is made one month after the end of the anticoagulant treatment or in 12th month after the beginning of the disease if the treatment goes on.

For each sample, the investigators perform a thrombin generation test and a D-Dimers measurement.

ReferenceCitation: Triquenot Bagan A, Crassard I, Drouet L, Barbieux-Guillot M, Marlu R, Robinet-Borgomino E, Morange PE, Wolff V, Grunebaum L, Klapczynski F, Andre-Kerneis E, Pico F, Martin-Bastenaire B, Ellie E, Menard F, Rouanet F, Freyburger G, Godeneche G, Allano HA, Moulin T, Mourey G, Derex L, Berruyer M, Runavot G, Trichet C, Viader F, Le Querrec A, Husein TT, Cluet-Dennetiere S, Macian-Montoro F, Donnard M, Guillon B, Ternisien C, Zuber M, Laplanche S, Tassan P, Peeltier JY, Canaple S, Roussel B, Gaillard N, Scavazza E, Le Cam Duchez V. Cerebral Venous Thrombosis: Clinical, Radiological, Biological, and Etiological Characteristics of a French Prospective Cohort (FPCCVT)-Comparison With ISCVT Cohort. Front Neurol. 2021 Nov 8;12:753110. doi: 10.3389/fneur.2021.753110. eCollection 2021.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

lead_sponsor: University Hospital, Rouen

location_facility:
Chu D' Angers
C.H.U. Limoges
C.H. Yves Le Foll
C.H. Saint-Denis
C.H. de Versailles
Hôpital Pellegrin - CHU Bordeaux
Hôpital de la Cavale Blanche
Hôpital Nord de Laënnec
C.H. de Compiègne
C.H. François Quesnay
G.H. Paris Saint-Joseph
C.H.U de Poitiers
C.H.U de Strasbourg
CHRU Bretonneau
C.H. de Perpignan - Hôpital Saint-Jean
Hôpital J. Monod
Ch Victor Dupouy
C.H.U. de Grenoble
Hôpital de la Timone
CH Côte Basque
Chu Amiens
Hôpitaux Civils de Colmar
C.H.I. Eure-Seine
CHU hopitaux de rouen
Hôpital Côte de Nacre
Hôpital Guy de Chauliac
C.H. de Meaux
C.H. de La Rochelle
CHI de Poissy- site de Poissy
CHU Estaing
Hôpital Henri Mondor
GH Pitié-Salpêtrière
Hôpital Jean Minjioz
G.H.U. Carémeau
CHU-Hôpital Général
Hôpital Neurologique de Lyon


title: Description of Sign-and-symptom Associations at Acromegaly Diagnosis.

acronym: ACRO-POLIS

summary: The purpose of this study is to describe most characteristic association of signs and symptoms present at the time of acromegaly diagnosis.

time_perspective: Retrospective

ReferenceCitation: Caron P, Brue T, Raverot G, Tabarin A, Cailleux A, Delemer B, Renoult PP, Houchard A, Elaraki F, Chanson P. Signs and symptoms of acromegaly at diagnosis: the physician's and the patient's perspectives in the ACRO-POLIS study. Endocrine. 2019 Jan;63(1):120-129. doi: 10.1007/s12020-018-1764-4. Epub 2018 Sep 29. Erratum In: Endocrine. 2018 Oct 31;:

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

lead_sponsor: Ipsen

location_facility: Chu de Grenoble Hôpital Albert Michallon

lead_sponsor_type: industriel


title: Impact of Drug Reconciliation at Discharge and Pharmaceutical Communication Between Hospital and Community Pharmacists on Drug Related Problems: Study Protocol for a Cluster Randomized Cross-over Trial

acronym: REPHVIM

summary: This study will evaluate the impact of a communication between hospital pharmacist and community pharmacists in addition to drugs reconciliation procedure at discharge. It will be conducted in 21 french public hospitals.

status: Unknown status

design_allocation: Randomized

ReferenceCitation: Pourrat X, Roux C, Bouzige B, Garnier V, Develay A, Allenet B, Fraysse M, Halimi JM, Grassin J, Giraudeau B. Impact of drug reconciliation at discharge and communication between hospital and community pharmacists on drug-related problems: study protocol for a randomized controlled trial. Trials. 2014 Jun 30;15:260. doi: 10.1186/1745-6215-15-260.

repositories_concat: PubMed Central

publisher_dissemination: Springer

lead_sponsor: University Hospital, Tours

location_facility:
CHU Conception
Hopital de Mercy Metz-Thionville
Hopital Archet
Hopital Inter Armées
Hopital de Hautepierre
Hopital Jacques Monod
Centre Hospitalier
Hopital de la Cavale Blanche
Centre Hospitalier Alès-Cévennes
Hopital ESTAING
Centre Hospitalier Pierre Bérégovoy
Centre Hospitalier Universitaire
Centre Hospitalier Compiègne-Noyon
Hopitaux civils de Colmar

status_simplified: Unknown


title: Evaluation of the Efficacy and Safety of Use of an Innovative Medical Device for Improving Oral Accessibility in People With Disabilities, Presenting Behavioral Disorders: The Oral Accessibility Spatula (Spatule SAB)

acronym: SAB

summary: The purpose of this study is to evaluate the efficiency and the safe use of a new medical device to improve the oral accessibility of disabled people during the oral-dental examination.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
CHRU Nancy
CHRU Strasbourg
CHR METZ THIONVILLE- Bel-Air Hospital
Centre Hospitalier Emile Durkheim
CHU Dijon
Clinique Saint Francois
CHR Metz-Thionville- Mercy Hospital

intervention_type: Device


title: A Randomized Study Comparing the Incidence of Acute Clinical or Subclinical Rejection With Two Dosing Regimens of CellCept in de Novo Renal Transplant Recipients Receiving Induction, Cyclosporine and Brief Steroid Therapy

summary: This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and early discontinuation of steroids. Patients will be randomized to one of the two treatment arms. The anticipated time on study treatment is 52 weeks.

primary_purpose: Treatment

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug


type: EudraCT Number

title: Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)

summary: Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.

primary_purpose: Prevention

ReferenceCitation: Mohkam K, Rayar M, Adam JP, Muscari F, Rode A, Merle P, Pradat P, Bauler S, Delfour I, Chiche L, Ducerf C, Boudjema K, Lesurtel M, Laurent C, Mabrut JY. Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT). BMC Cancer. 2018 Aug 23;18(1):844. doi: 10.1186/s12885-018-4667-0.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse

appel_a_projets: PHRCK

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

titre: SOMAPROTECT01 Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: Multicenter randomized double-blind placebo controlled trial

discipline_principale: cancer

nom_porteur: MOHKAM

prenom_porteur: Kayvan


title: Evaluation of Individual Radiosensitivity of Cancer Patients to be Treated by Radiotherapy or Radiochemotherapy Per-operative

acronym: THEODORA

summary: THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A & MS bioassays on tumor control by radiotherapy.

status: Terminated

ReferenceType: background

ReferenceCitation: Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. doi: 10.1002/cncr.21324. Erratum In: Cancer. 2006 Aug 1;107(3):660.

ReferenceCitation: Bentzen SM, Heeren G, Cottier B, Slotman B, Glimelius B, Lievens Y, van den Bogaert W. Towards evidence-based guidelines for radiotherapy infrastructure and staffing needs in Europe: the ESTRO QUARTS project. Radiother Oncol. 2005 Jun;75(3):355-65. doi: 10.1016/j.radonc.2004.12.007. Epub 2005 Mar 16.

ReferenceCitation: Lievens Y, Grau C. Health economics in radiation oncology: introducing the ESTRO HERO project. Radiother Oncol. 2012 Apr;103(1):109-12. doi: 10.1016/j.radonc.2011.12.026. Epub 2012 Feb 8.

ReferenceCitation: Dorr W, Hendry JH. Consequential late effects in normal tissues. Radiother Oncol. 2001 Dec;61(3):223-31. doi: 10.1016/s0167-8140(01)00429-7.

ReferenceCitation: Bodgi L, Granzotto A, Devic C, Vogin G, Lesne A, Bottollier-Depois JF, Victor JM, Maalouf M, Fares G, Foray N. A single formula to describe radiation-induced protein relocalization: towards a mathematical definition of individual radiosensitivity. J Theor Biol. 2013 Sep 21;333:135-45. doi: 10.1016/j.jtbi.2013.05.020. Epub 2013 Jun 2.

ReferenceCitation: Foray N, Colin C, Bourguignon M. 100 years of individual radiosensitivity: how we have forgotten the evidence. Radiology. 2012 Sep;264(3):627-31. doi: 10.1148/radiol.12112560. No abstract available.

ReferenceCitation: Joubert A, Zimmerman KM, Bencokova Z, Gastaldo J, Chavaudra N, Favaudon V, Arlett CF, Foray N. DNA double-strand break repair defects in syndromes associated with acute radiation response: at least two different assays to predict intrinsic radiosensitivity? Int J Radiat Biol. 2008 Feb;84(2):107-25. doi: 10.1080/09553000701797039.

ReferenceCitation: Granzotto A, Joubert A, Viau M, Devic C, Maalouf M, Thomas C, Vogin G, Malek K, Colin C, Balosso J, Foray N. [Individual response to ionising radiation: What predictive assay(s) to choose?]. C R Biol. 2011 Feb;334(2):140-57. doi: 10.1016/j.crvi.2010.12.018. French.

ReferenceCitation: Rothkamm K, Lobrich M. Evidence for a lack of DNA double-strand break repair in human cells exposed to very low x-ray doses. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5057-62. doi: 10.1073/pnas.0830918100. Epub 2003 Apr 4.

ReferenceCitation: COPERNIC project investigators; Granzotto A, Benadjaoud MA, Vogin G, Devic C, Ferlazzo ML, Bodgi L, Pereira S, Sonzogni L, Forcheron F, Viau M, Etaix A, Malek K, Mengue-Bindjeme L, Escoffier C, Rouvet I, Zabot MT, Joubert A, Vincent A, Dalla Venezia N, Bourguignon M, Canat EP, d'Hombres A, Thebaud E, Orbach D, Stoppa-Lyonnet D, Radji A, Dore E, Pointreau Y, Bourgier C, Leblond P, Defachelles AS, Lervat C, Guey S, Feuvret L, Gilsoul F, Berger C, Moncharmont C, de Laroche G, Moreau-Claeys MV, Chavaudra N, Combemale P, Biston MC, Malet C, Martel-Lafay I, Laude C, Hau-Desbat NH, Zioueche A, Tanguy R, Sunyach MP, Racadot S, Pommier P, Claude L, Baleydier F, Fleury B, de Crevoisier R, Simon JM, Verrelle P, Peiffert D, Belkacemi Y, Bourhis J, Lartigau E, Carrie C, De Vathaire F, Eschwege F, Puisieux A, Lagrange JL, Balosso J, Foray N. Influence of Nucleoshuttling of the ATM Protein in the Healthy Tissues Response to Radiation Therapy: Toward a Molecular Classification of Human Radiosensitivity. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):450-60. doi: 10.1016/j.ijrobp.2015.11.013. Epub 2015 Nov 14.

ReferenceCitation: Bodgi L, Foray N. The nucleo-shuttling of the ATM protein as a basis for a novel theory of radiation response: resolution of the linear-quadratic model. Int J Radiat Biol. 2016;92(3):117-31. doi: 10.3109/09553002.2016.1135260.

ReferenceCitation: Zaider M, Minerbo GN. Tumour control probability: a formulation applicable to any temporal protocol of dose delivery. Phys Med Biol. 2000 Feb;45(2):279-93. doi: 10.1088/0031-9155/45/2/303.

ReferenceCitation: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

ReferenceCitation: Gerard A, Buyse M, Nordlinger B, Loygue J, Pene F, Kempf P, Bosset JF, Gignoux M, Arnaud JP, Desaive C, et al. Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC). Ann Surg. 1988 Nov;208(5):606-14. doi: 10.1097/00000658-198811000-00011.

ReferenceCitation: Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.

ReferenceCitation: Fleming FJ, Pahlman L, Monson JR. Neoadjuvant therapy in rectal cancer. Dis Colon Rectum. 2011 Jul;54(7):901-12. doi: 10.1007/DCR.0b013e31820eeb37.

ReferenceCitation: Movsas B, Diratzouian H, Hanlon A, Cooper H, Freedman G, Konski A, Sigurdson E, Hoffman J, Meropol NJ, Weiner LM, Coia L, Lanciano R, Stein J, Kister D, Eisenberg B. Phase II trial of preoperative chemoradiation with a hyperfractionated radiation boost in locally advanced rectal cancer. Am J Clin Oncol. 2006 Oct;29(5):435-41. doi: 10.1097/01.coc.0000227480.41414.f2.

ReferenceCitation: Wagman R, Minsky BD, Cohen AM, Guillem JG, Paty PP. Sphincter preservation in rectal cancer with preoperative radiation therapy and coloanal anastomosis: long term follow-up. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):51-7. doi: 10.1016/s0360-3016(98)00180-1.

ReferenceCitation: Pisters PW, Harrison LB, Leung DH, Woodruff JM, Casper ES, Brennan MF. Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma. J Clin Oncol. 1996 Mar;14(3):859-68. doi: 10.1200/JCO.1996.14.3.859.

ReferenceCitation: Yang JC, Chang AE, Baker AR, Sindelar WF, Danforth DN, Topalian SL, DeLaney T, Glatstein E, Steinberg SM, Merino MJ, Rosenberg SA. Randomized prospective study of the benefit of adjuvant radiation therapy in the treatment of soft tissue sarcomas of the extremity. J Clin Oncol. 1998 Jan;16(1):197-203. doi: 10.1200/JCO.1998.16.1.197.

ReferenceCitation: Koshy M, Rich SE, Mohiuddin MM. Improved survival with radiation therapy in high-grade soft tissue sarcomas of the extremities: a SEER analysis. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):203-9. doi: 10.1016/j.ijrobp.2009.04.051. Epub 2009 Aug 11.

ReferenceCitation: Strander H, Turesson I, Cavallin-Stahl E. A systematic overview of radiation therapy effects in soft tissue sarcomas. Acta Oncol. 2003;42(5-6):516-31. doi: 10.1080/02841860310014732.

ReferenceCitation: Stacchiotti S, Collini P, Messina A, Morosi C, Barisella M, Bertulli R, Piovesan C, Dileo P, Torri V, Gronchi A, Casali PG. High-grade soft-tissue sarcomas: tumor response assessment--pilot study to assess the correlation between radiologic and pathologic response by using RECIST and Choi criteria. Radiology. 2009 May;251(2):447-56. doi: 10.1148/radiol.2512081403. Epub 2009 Mar 4.

ReferenceCitation: Stahl R, Wang T, Lindner LH, Abdel-Rahman S, Santl M, Reiser MF, Issels RD. Comparison of radiological and pathohistological response to neoadjuvant chemotherapy combined with regional hyperthermia (RHT) and study of response dependence on the applied thermal parameters in patients with soft tissue sarcomas (STS). Int J Hyperthermia. 2009 Jun;25(4):289-98. doi: 10.1080/02656730902873616.

ReferenceCitation: O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41. doi: 10.1016/S0140-6736(02)09292-9.

ReferenceCitation: Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.

ReferenceCitation: Ishikura S, Nihei K, Ohtsu A, Boku N, Hironaka S, Mera K, Muto M, Ogino T, Yoshida S. Long-term toxicity after definitive chemoradiotherapy for squamous cell carcinoma of the thoracic esophagus. J Clin Oncol. 2003 Jul 15;21(14):2697-702. doi: 10.1200/JCO.2003.03.055.

ReferenceCitation: Morota M, Gomi K, Kozuka T, Chin K, Matsuura M, Oguchi M, Ito H, Yamashita T. Late toxicity after definitive concurrent chemoradiotherapy for thoracic esophageal carcinoma. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):122-8. doi: 10.1016/j.ijrobp.2008.10.075. Epub 2009 Mar 26.

ReferenceCitation: Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.

lead_sponsor: Centre Leon Berard

location_facility: Hopital Nord Ouest Villefranche Sur Saone

location_facility: ICL - Institut de Cancérologie de la Lorraine

intervention_type: Radiation


title: Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.

acronym: REPERE

summary:
The main objective is to assess the role of antenatal detection of fetal growth restriction (FGR) on stillbirth, by a case-control study in a population-based sample of small for gestational age (SGA) livebirths and stillbirths in 3 French counties (Isère, Savoie and Haute-Savoie). SGA births will be defined as a birthweight below the 10th percentile of French customised birth weight curves.

Our secondary objectives are

to identify determinants of antenatal detection of FGR among a representative sample of SGA births, with a special interest in the definition of FGR. Our hypothesis is that births who are SGA by customised birthweight curves and non-SGA by population birthweight curves, are not detected antenatally, despite the current strategy including the use of umbilical Doppler.
to analyse prenatal care of a subsample of SGA stillbirths with and without detection of FGR by a confidential enquiry.

ReferenceCitation: Altman DG, Hytten FE. Intrauterine growth retardation: let's be clear about it. Br J Obstet Gynaecol. 1989 Oct;96(10):1127-32. doi: 10.1111/j.1471-0528.1989.tb03185.x. No abstract available.

ReferenceCitation: Pardi G, Marconi AM, Cetin I. Placental-fetal interrelationship in IUGR fetuses--a review. Placenta. 2002 Apr;23 Suppl A:S136-41. doi: 10.1053/plac.2002.0802.

ReferenceCitation: Kaufmann P SI. Placental development. In: Polin RA FW, eds, editor. Fetal and neonatal physiology. Philadelphia: WB Saunders, 1998:59-70.

ReferenceCitation: Baschat AA. Pathophysiology of fetal growth restriction: implications for diagnosis and surveillance. Obstet Gynecol Surv. 2004 Aug;59(8):617-27. doi: 10.1097/01.ogx.0000133943.54530.76.

ReferenceCitation: Hecher K, Snijders R, Campbell S, Nicolaides K. Fetal venous, intracardiac, and arterial blood flow measurements in intrauterine growth retardation: relationship with fetal blood gases. Am J Obstet Gynecol. 1995 Jul;173(1):10-5. doi: 10.1016/0002-9378(95)90161-2.

ReferenceCitation: Severi FM, Bocchi C, Visentin A, Falco P, Cobellis L, Florio P, Zagonari S, Pilu G. Uterine and fetal cerebral Doppler predict the outcome of third-trimester small-for-gestational age fetuses with normal umbilical artery Doppler. Ultrasound Obstet Gynecol. 2002 Mar;19(3):225-8. doi: 10.1046/j.1469-0705.2002.00652.x.

ReferenceCitation: Haws RA, Yakoob MY, Soomro T, Menezes EV, Darmstadt GL, Bhutta ZA. Reducing stillbirths: screening and monitoring during pregnancy and labour. BMC Pregnancy Childbirth. 2009 May 7;9 Suppl 1(Suppl 1):S5. doi: 10.1186/1471-2393-9-S1-S5.

ReferenceCitation: Imdad A, Yakoob MY, Siddiqui S, Bhutta ZA. Screening and triage of intrauterine growth restriction (IUGR) in general population and high risk pregnancies: a systematic review with a focus on reduction of IUGR related stillbirths. BMC Public Health. 2011 Apr 13;11 Suppl 3(Suppl 3):S1. doi: 10.1186/1471-2458-11-S3-S1.

ReferenceCitation: Alfirevic Z, Neilson JP. Doppler ultrasonography in high-risk pregnancies: systematic review with meta-analysis. Am J Obstet Gynecol. 1995 May;172(5):1379-87. doi: 10.1016/0002-9378(95)90466-2.

ReferenceCitation: Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. doi: 10.1002/14651858.CD001451.

ReferenceCitation: Bricker L, Neilson JP, Dowswell T. Routine ultrasound in late pregnancy (after 24 weeks' gestation). Cochrane Database Syst Rev. 2008 Oct 8;(4):CD001451. doi: 10.1002/14651858.CD001451.pub3.

ReferenceCitation: Neilson JP AZ. Doppler ultrasound for fetal assessment in high risk pregnancies (Cochrane review). The Cochrane Library, Issue 1, Oxford:Update software, 2002.

ReferenceCitation: GRIT Study Group. A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation. BJOG. 2003 Jan;110(1):27-32. doi: 10.1046/j.1471-0528.2003.02014.x.

ReferenceCitation: Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M; GRIT study group. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet. 2004 Aug 7-13;364(9433):513-20. doi: 10.1016/S0140-6736(04)16809-8.

ReferenceCitation: Bais JM, Eskes M, Pel M, Bonsel GJ, Bleker OP. Effectiveness of detection of intrauterine growth retardation by abdominal palpation as screening test in a low risk population: an observational study. Eur J Obstet Gynecol Reprod Biol. 2004 Oct 15;116(2):164-9. doi: 10.1016/j.ejogrb.2004.01.037.

ReferenceCitation: Jahn A, Razum O, Berle P. Routine screening for intrauterine growth retardation in Germany: low sensitivity and questionable benefit for diagnosed cases. Acta Obstet Gynecol Scand. 1998 Jul;77(6):643-8. doi: 10.1034/j.1600-0412.1998.770611.x.

ReferenceCitation: Mattioli KP, Sanderson M, Chauhan SP. Inadequate identification of small-for-gestational-age fetuses at an urban teaching hospital. Int J Gynaecol Obstet. 2010 May;109(2):140-3. doi: 10.1016/j.ijgo.2009.11.023. Epub 2010 Feb 2.

ReferenceCitation: Lindqvist PG, Molin J. Does antenatal identification of small-for-gestational age fetuses significantly improve their outcome? Ultrasound Obstet Gynecol. 2005 Mar;25(3):258-64. doi: 10.1002/uog.1806.

ReferenceCitation: Ogundipe EM, Wolfe CD, Seed P, Gamsu HR. Does the antenatal detection of small-for-gestational-age babies influence their two-year outcomes? Am J Perinatol. 2000;17(2):73-81. doi: 10.1055/s-2000-9273.

ReferenceCitation: Fretts RC, Boyd ME, Usher RH, Usher HA. The changing pattern of fetal death, 1961-1988. Obstet Gynecol. 1992 Jan;79(1):35-9.

lead_sponsor: University Hospital, Grenoble

collaborators: Registre de Handicap de l'Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie

collaborators: UMRS 953, Epidemiological Research Unit on Perinatal and Women's and Children's Health, INSERM

location_facility: Clinique Saint Vincent de Paul Bourgoin Jallieu


title: A Phase I-II Study of NBTXR3 Activated by Sterostatic Body Radiation Therapy (SBRT) In the Treatment of Liver Cancers

summary: The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers.

lead_sponsor: Nanobiotix

location_facility:
Institut de Cancérologie de Loraine
CHU de NANCY
CHU La Croix Rousse
Institut Gustave Roussy
Centre Eugène Marquis
Hôpital Haut-Lévêque
Centre René Gauducheau


title: Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study

acronym: HYPERION

summary:
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

ReferenceCitation: Ziriat I, Le Thuaut A, Colin G, Merdji H, Grillet G, Girardie P, Souweine B, Dequin PF, Boulain T, Frat JP, Asfar P, Francois B, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Massart N, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Reignier J, Cariou A, Lascarrou JB. Outcomes of mild-to-moderate postresuscitation shock after non-shockable cardiac arrest and association with temperature management: a post hoc analysis of HYPERION trial data. Ann Intensive Care. 2022 Oct 17;12(1):96. doi: 10.1186/s13613-022-01071-z.

ReferenceCitation: Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Lascarrou JB, Meziani F, Le Gouge A, Boulain T, Bousser J, Belliard G, Asfar P, Frat JP, Dequin PF, Gouello JP, Delahaye A, Hssain AA, Chakarian JC, Pichon N, Desachy A, Bellec F, Thevenin D, Quenot JP, Sirodot M, Labadie F, Plantefeve G, Vivier D, Girardie P, Giraudeau B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group and HYPERION Study Group. Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial. Scand J Trauma Resusc Emerg Med. 2015 Mar 7;23:26. doi: 10.1186/s13049-015-0103-5.

lead_sponsor: Centre Hospitalier Departemental Vendee

sponsor_collaborators:
Centre Hospitalier Departemental Vendee
University Hospital, Tours

location_country: Guadeloupe France

location_facility:
Medical Surgical Intensive Care Unit
Medical Intensive Care Unit
CHU Pointe à Pitre
Cochin University Hospital Center

intervention_type: Procedure


lead_sponsor: UNICANCER

summary: The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.

sponsor_collaborators:
UNICANCER
Ferring Pharmaceuticals

location_facility: Centre d'oncologie et de radiothérapie du Parc

location_facility: Groupe Oncorad Garonne Clinique Du Pont de Chaume

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

location_facility: Hôpital d'Instruction des Armées du Val de Grâce

location_facility: GUSTAVE ROUSSY, Cancer Campus, Grand Paris

location_facility: Institut de Cancérologie LUCIEN NEUWIRTH

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau

status: Active, not recruiting

title: A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy

source: euctr

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


title: Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.

acronym: STIMCONE

summary:
Pudendal neuralgia is a frequent diagnosis in pain clinics. This perineal pain has devastating effects on patient's quality of life. Today, 30% of patients are refractory to pain management and surgical procedure.

The neuropathic characteristics of the pain in these patients lead us to test the efficiency of spinal cord stimulation at conus medullaris level.

In our published preliminary study involving 27 patients with refractory pudendal neuralgia, we demonstrated that 74% of patients implanted with stimulation electrodes at the conus medullaris responded to stimulation.

The primary objective of the present trial is to assess through a randomized, parallel group design, the effectiveness of spinal cord stimulation at the conus medullaris using pentapolar surgical lead ((TM)Penta, St Jude medical ANS) versus medical treatment alone on sitting time in refractory pudendal neuralgia.

lead_sponsor: Nantes University Hospital

location_facility:
Lyon University Hospital
Nantes Hospital
Hôpital Foch
Colmar Hospital
Lille University Hospital
Clinic Catherine de Sienne
Bordeaux University Hospital

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: StimCone

titre: Stimulation du cône médullaire par électrodes 5 colonnes versus traitement médical dans les névralgies pudendales réfractaires : un essai randomisé, contrôlé, multicentrique.

discipline_principale: urologie

nom_porteur: BUFFENOIR

prenom_porteur: Kevin


acronym: OAsIs

summary:
This is an open label, multicenter, fixed dose and dose escalation, phase I/II study.

The study will be conducted in 3 steps. The first one (step A) will be to ensure the safety of the combination of Obinutuzumab (GA101) and Ibrutinib at fixed doses in patients with relapsed or refractory Mantle Cell Lymphoma (MCL).

A total of 9 patients have been included in the first step with grouped inclusions of three patients (safety evaluation performed at each inclusion of 3 patients).

No unacceptable toxicity has been observed during step A, thefore the second step (step B) was initiated. The aim of the second step was to determine the MTD of the GDC-0199 (400-600-800mg/d) in combination of GA101 and Ibrutinib (both respecting the previous doses) by using a Continual Reassessment Method. This dose escalation method was used until the 12th patient (3 patients included at 400mg/d of GDC-0199-(no DLT), 3 at 600mg/d- (no DLT) and 6 at 800mg/d, (not DLT reported so far). Once the last patient of the 800mg cohort is evaluated for DLT, all other patients will be treated at the dose of 400mg/d of GDC-0199.

The third step (step C) for untreated patients will be conducted at the dose of 400mg/d of GDC-0199. The aim of step C is to confirm the safety profile of the GA101 + Ibrutininb + GDC-199 combination according to step B result. 15 patients will be included in this step.

ReferenceCitation: Le Gouill S, Morschhauser F, Chiron D, Bouabdallah K, Cartron G, Casasnovas O, Bodet-Milin C, Ragot S, Bossard C, Nadal N, Herbaux C, Tessoulin B, Tchernonog E, Rossi C, McCulloch R, Gastinne T, Callanan MB, Rule S. Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial. Blood. 2021 Feb 18;137(7):877-887. doi: 10.1182/blood.2020008727.

publisher_dissemination: American Society of Hematology

sponsor_collaborators:
Nantes University Hospital
Janssen, LP
Roche Pharma AG

location_facility: Derriford Hospital _ Plymouth Hospitals NHS Trust

title: A Phase I/II Trial of Obinutuzumab, ABT-199 (GDC-0199) Plus Ibrutinib in Relapsed / Refractory Mantle Cell Lymphoma Patients

location_country:
United Kingdom
France

collaborators:
Janssen, LP
Roche Pharma AG


title: IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A

summary: This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.


summary:
This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma.

Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.

location_facility: Centre Hospitalier intercommunale Meulan les mureaux

location_facility: Centre Hospitalier de la région d'Annecy

title: A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA."


lead_sponsor: Chiesi Farmaceutici S.p.A.

summary: Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.

ReferenceType: result

ReferenceCitation: Kamar N, Cassuto E, Piotti G, Govoni M, Ciurlia G, Geraci S, Poli G, Nicolini G, Mariat C, Essig M, Malvezzi P, Le Meur Y, Garrigue V, Del Bello A, Rostaing L. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Adv Ther. 2019 Feb;36(2):462-477. doi: 10.1007/s12325-018-0855-1. Epub 2018 Dec 14.

license: cc-by-nc

license_normalized: cc-by-nc

location_facility: CHU Rangueil, 1 avenue J Poulhes TSA 50032.

location_facility: Nephrology department CHU de Saint-Etienne Hospital Nord

location_facility: Nephrology Department Hopital La Cavale Blanche

location_facility: Unité de transplantation rénale -Hopital Pasteur

title: OPEN-LABEL, MULTICENTRE, RANDOMIZED CLINICAL TRIAL TO COMPARE THE PHARMACOKINETICS OF ENVARSUS® TABLETS AND ADVAGRAF® CAPSULES ADMINISTERED ONCE DAILY IN ADULT DE-NOVO KIDNEY TRANSPLANT PATIENTS


title: Phase II Study of NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma

acronym: FOXAGAST

summary:
This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study.

In neoadjuvant setting : 3 months of treatment

Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable toxicity, or patient decision.

Post-operative treatment (for 6 additional cycles) is recommended, but will depend on the result of the neo-adjuvant treatment and the ability of patients to receive adjuvant chemotherapy based on tolerance of neo-adjuvant treatment and general post-operative condition (i.e. adjuvant treatment if no progression during neo-adjuvant chemotherapy, less than 80% of residual viable tumor compared to initial tumor volume, acceptable tolerance and post-operative PS 0 - 2). Adjuvant treatment must be initiated within 8 weeks post-operatively.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: Oedematous Lower Limb Subcutaneous Drainage in Palliative Care

acronym: DSOPAL

summary:
Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. In case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. The technique is simple, easy to use but remains off the record. Since 2004, 23 cases were reported with various methods. All the cases reported were undertaken with various technical approaches and efficacy criteria.
Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in QOL in terms of behavioral and autonomy.

lead_sponsor: University Hospital, Limoges

location_facility:
Joseph Ducuing hospital
University hospital
Hospital

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: DSOPAL

titre: Drainage sous-cutané des dèmes des membres inférieurs en soins palliatifs

nom_porteur: SARDIN

prenom_porteur: Bertrand


title: In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III

acronym: FIBRATLAS

summary:
White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. These tracts form the internal part of the brain and transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for numerous neurological diseases.

Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. Since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. Several validation techniques were previously proposed, none of them being fully convincing in human.

location_facility:
University Hospital of Angers
University Hospital of Rennes
University Hospital of Tours
Hospital of Charpennes - Lyon
University Hospital of Brest
University Hospital of Nancy
University Hospital of Amiens


title: Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer - A Prospective Observational Study in Elderly Patients With Non-small Cells Lung Cancer

acronym: OPERAGE

summary: schema : Prospective prognostic study The main objective is to study the value of the Comprehensive Geriatric Assessment in predicting the risk of post operative complications after lung resection for cancer.

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 42
Site 12
Site 19
Centre Hospitalier Les Oudairies
Site 04
Site 06
Site 07
Site 17
Hospital Saint Antoine
Site 18
Site 20
Centre Hospitalier René Dubos
Site 33
Centre Hospitalier du Morvan
Hôpital Yves Le Foll
Centre François Baclesse
Site 30
Site 32
Site 11
Centre Hospitalier Régional
Hospital du Cluzeau
Centre Hospitalier D Argenteuil
Site 14
Site 41
Centre Hospitalier Universitaire


acronym: SERODIFF

summary:
Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be predict the Clostridium difficile infection.

This study evaluates the weight of immunity by studying patients with Clostridium difficile infection versus controls (each patient is associated with two controls : diarrheal control without Clostridium difficile, and non-diarrheal control with or without Clostridium difficile). Recurrence and the kinetics of immune response following infection Clostridium difficile are studied by following the patients during three months.

There are also building biological samples collections clinically documented: sera, stool and strains.

design_allocation: Non-Randomized

lead_sponsor: Versailles Hospital

sponsor_collaborators:
Versailles Hospital
Institut Pasteur
Sanofi Pasteur, a Sanofi Company
Saint Antoine University Hospital

location_facility: Groupe Hospitalier Sainte-Périne / Rossini / Chardon Lagache

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

intervention_type: Biological


title: Open-label, Multicenter, Dose-escalating Phase II Study to Investigate the Safety, Tolerability, and Early Signs of Efficacy of Subcutaneous Administrations of Tadekinig Alfa (IL-18BP) in Patients With Adult -Onset Still's Disease (AoSD) During 12 Weeks

summary:
The objective of this study is to assess safety, tolerability and early signs of efficacy of the investigational drug Tadekinig alfa in Adult-onset Still's disease, a rare polygenic auto-inflammatory disorder for which treatment remains empirical.

This disease is characterized by a daily spiking fever, arthralgia / arthritis, and skin rashes with frequent components of sore throat, lymphadenopathies and neutrophilic leukocytosis. The etiology is unknown. In addition to the above-mentioned clinical features, the diagnosis includes some laboratory components that reflect the systemic inflammation: high erythro-sedimentation rate, C-reactive protein, high serum ferritin and high levels of interleukin 18 (IL-18).

Tadekinig alfa is the drug name for recombinant human interleukin-18 binding protein (IL-18BP). This investigational drug was tested in healthy volunteers, psoriasis and rheumatoid arthritis patients in phase I studies. It demonstrated good safety and tolerability profile with only mild adverse events in the injection site.

ReferenceCitation: Bagnari V, Colina M, Ciancio G, Govoni M, Trotta F. Adult-onset Still's disease. Rheumatol Int. 2010 May;30(7):855-62. doi: 10.1007/s00296-009-1291-y. Epub 2009 Dec 18.

ReferenceCitation: Bywaters EG. Still's disease in the adult. Ann Rheum Dis. 1971 Mar;30(2):121-33. doi: 10.1136/ard.30.2.121. No abstract available.

ReferenceCitation: Efthimiou P, Kontzias A, Ward CM, Ogden NS. Adult-onset Still's disease: can recent advances in our understanding of its pathogenesis lead to targeted therapy? Nat Clin Pract Rheumatol. 2007 Jun;3(6):328-35. doi: 10.1038/ncprheum0510.

ReferenceCitation: Fautrel B. Adult-onset Still disease. Best Pract Res Clin Rheumatol. 2008 Oct;22(5):773-92. doi: 10.1016/j.berh.2008.08.006.

ReferenceCitation: Kawashima M, Yamamura M, Taniai M, Yamauchi H, Tanimoto T, Kurimoto M, Miyawaki S, Amano T, Takeuchi T, Makino H. Levels of interleukin-18 and its binding inhibitors in the blood circulation of patients with adult-onset Still's disease. Arthritis Rheum. 2001 Mar;44(3):550-60. doi: 10.1002/1529-0131(200103)44:33.0.CO;2-5.

ReferenceCitation: Yamaguchi M, Ohta A, Tsunematsu T, Kasukawa R, Mizushima Y, Kashiwagi H, Kashiwazaki S, Tanimoto K, Matsumoto Y, Ota T, et al. Preliminary criteria for classification of adult Still's disease. J Rheumatol. 1992 Mar;19(3):424-30.

ReferenceCitation: Gabay C, Fautrel B, Rech J, Spertini F, Feist E, Kotter I, Hachulla E, Morel J, Schaeverbeke T, Hamidou MA, Martin T, Hellmich B, Lamprecht P, Schulze-Koops H, Courvoisier DS, Sleight A, Schiffrin EJ. Open-label, multicentre, dose-escalating phase II clinical trial on the safety and efficacy of tadekinig alfa (IL-18BP) in adult-onset Still's disease. Ann Rheum Dis. 2018 Jun;77(6):840-847. doi: 10.1136/annrheumdis-2017-212608. Epub 2018 Feb 22.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

repository_institution: Université de Lausanne - SERVAL

repository_institution: University of Geneva - Archive ouverte UNIGE

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

repository_institution: McGill - eScholarship@McGill

publisher_dissemination: British Medical Journal

ipd_sharing: Undecided

lead_sponsor: AB2 Bio Ltd.

location_country: Germany Switzerland France

location_facility: Innere Medizin II - Rheumatologie Schlosspark-Klinik

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Universitätsklinikum Jena Klinik für Innere Medizin III Rheumatologie/Osteologie

location_facility: UNIVERSITÄTSMEDIZIN der Johannes-Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik Rheumatologie

location_facility: St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Rheumazentrum Ruhrgebiet

location_facility: Medizinische Klinik - Rheumatologie und Klinische

location_facility: CHU Paris-GH La Pitié Salpêtrière-Charles Foix - Hôpital Pitié-Salpêtrière


title: Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy

acronym: ENDOTHELION

summary: Acute ischemic optic neuropathy are the second leading cause of optic neuropathy after glaucoma in the population aged over 50 years. The visual prognosis of the condition is unfavorable in the great majority of cases, with significant effects on the visual field and vision. The severity of the unilateral condition is also associated with bilateralization in 15% at 5 years. There is no effective treatment for the acute phase of the disease or to reduce the rate of bilateralization. In this context, it is essential to develop new therapeutic strategies in the acute phase of the disease to reduce the anatomical optic nerve damage.

ReferenceCitation: Chiquet C, Vignal C, Gohier P, Heron E, Thuret G, Rougier MB, Lehmann A, Flet L, Quesada JL, Roustit M, Milea D, Pepin JL; ENDOTHELION group. Treatment of nonarteritic anterior ischemic optic neuropathy with an endothelin antagonist: ENDOTHELION (ENDOTHELin antagonist receptor in Ischemic Optic Neuropathy)-a multicentre randomised controlled trial protocol. Trials. 2022 Oct 29;23(1):916. doi: 10.1186/s13063-022-06786-9.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

location_facility: University Hospital of Grenoble Michallon

location_facility: Ophtalmological fondation of Rothschild + Bichat Hospital


title: Phase 3 Prospective, Multicentric Randomized Study of Endoscopic Versus Surgical Treatment of Bile Duct Stricture in Chronic Pancreatitis

acronym: PASTEC

summary:
Biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and in these cases, endoscopy and surgery are the treatment modalities of choice. Morbid-mortality of these procedures is similar and physicians face the decision between endoscopy and surgery for this group of patients, with no randomized controlled trial available comparing these procedures.

The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of surgical and endoscopic interventions in the management of bile duct stricture for chronic pancreatitis.

The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary end points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical procedures, length of stay. Eighty-six patients need to be included.

lead_sponsor: University Hospital, Lille

location_facility:
Hôpital St Philibert
Centre hospitalier
Clinique de la Louvière
Centre Hospitalier Dr Schaffner


title: Moderate Hypofractionated Radiotherapy (62 Gy in 20 Fractions of 3.1 Gy) Versus Stereotactic Radiotherapy (37.5 Gy in 5 Fractions of 7.5 Gy) With Hyaluronic Acid Injection Between the Prostate and the Rectum for Prostate Cancer of Low- to Intermediate Risk; RPAH2

summary:
The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.

Ninety-six patients and 9 centers are included in the protocol.

ReferenceCitation: Jmour O, Benna M, Champagnol P, Ben Mrad M, Hamrouni A, Obeid L, Lahmamssi C, Bousarsar A, Vial N, Rehailia-Blanchard A, Sotton S, Lan M, Langrand-Escure J, Vallard A, Magne N. CBCT evaluation of inter- and intra-fraction motions during prostate stereotactic body radiotherapy: a technical note. Radiat Oncol. 2020 Apr 19;15(1):85. doi: 10.1186/s13014-020-01534-2.

location_facility: Site Hospitalier Nord Boulevard Jacques Monod

location_facility: Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard


title: Relationship Between Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

acronym: PHYSICOSMICI

summary: This study is an observational study. The purpose of this study is to assess the relationship between bone health and daily physical activity in children and adolescents with inflammatory bowel disease (IBD). Reduced bone mineral density is a common complication in pediatric IBD. Physical activity is an important determinant of health throughout the whole lifespan. Engaging in regular moderate-to-vigorous physical activity has important health benefits. Based on available evidence, the investigators hypothesize that daily moderate-to-vigorous physical activity could improve bone health (ie bone mineral density) in children and adolescents with IBD.

time_perspective: Cross-Sectional

location_facility:
Centre hospitalier
Centre Hospitalier St Vincent
Centre Hospitalier
Chu Amiens-Picardie - Site Sud
Clinical Investigation Center


summary: The purpose of this study is to determine the recommended dose of lenalidomide in subjects with relapse and refractory Waldenstrom Macroglobulinemia.

ReferenceCitation: Fouquet G, Guidez S, Petillon MO, Louni C, Ohyba B, Dib M, Poulain S, Herbaux C, Martin A, Thielemans B, Brice P, Choquet S, Bakala J, Bories C, Demarquette H, Nudel M, Tournilhac O, Arnulf B, LeGouill S, Morel P, Banos A, Karlin L, Salles G, Leblond V, Leleu X. Lenalidomide is safe and active in Waldenstrom macroglobulinemia. Am J Hematol. 2015 Nov;90(11):1055-9. doi: 10.1002/ajh.24175. Epub 2015 Oct 6.

publisher_dissemination: Wiley

sponsor_collaborators:
University Hospital, Lille
Celgene Corporation

location_facility:
Groupe hospitalier Pitié Salpétrière
Centre Hospitalier Lyon Sud
CH LENS
Ch Clermond Ferrand
Centre Hospitalier de la côte basque
Chru Lille
Ch Nantes

title: A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia


title: An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

acronym: PRISM

summary:
Primary objective:

To assess the efficacy of I10E in improving the disability of patients with CIDP.

Secondary objective:

To assess the safety of I10E in patients with CIDP.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_country:
Italy
United Kingdom
Tunisia
Spain
Turkey
France

location_facility: Marmara Universitesi Egitim Ve Arastirma Hastanesi

location_facility: Azienda Ospedaliere Universitaria san Giovanni

location_facility: Uludag University Medical School Neurology

location_facility: Hospital clinico Universitario de Santiago

location_facility: Ankara University medical School Neurology

location_facility: University Hospital of North Straffordshire

location_facility: Istanbul UniversityCerrahpasa Medical School Neurology

location_facility: IRRCS Istituto Nazionale Neurologico Besta

location_facility: Azienda Ospedaliere Universitaria di Padova

location_facility: Hospital Universitario i Politècnico La Fe

location_facility: Hacettepe University Medical School Neurology


title: Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation.

acronym: MITRA-FR

summary:
The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.

This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).

ReferenceCitation: Iung B, Messika-Zeitoun D, Boutitie F, Trochu JN, Armoiry X, Maucort-Boulch D, Obadia JF, Vahanian A. Characteristics and Outcome of COAPT-Eligible Patients in the MITRA-FR Trial. Circulation. 2020 Dec 22;142(25):2482-2484. doi: 10.1161/CIRCULATIONAHA.120.049743. Epub 2020 Dec 21. No abstract available.

evidence: open (via free pdf)

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Messika-Zeitoun D, Iung B, Armoiry X, Trochu JN, Donal E, Habib G, Brochet E, Thibault H, Piriou N, Cormier B, Tribouilloy C, Guerin P, Lefevre T, Maucort-Boulch D, Vahanian A, Boutitie F, Obadia JF. Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial. JACC Cardiovasc Imaging. 2021 Apr;14(4):742-752. doi: 10.1016/j.jcmg.2020.07.021. Epub 2020 Sep 16.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: HAL

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

publisher_dissemination: Elsevier

ReferenceCitation: Iung B, Armoiry X, Vahanian A, Boutitie F, Mewton N, Trochu JN, Lefevre T, Messika-Zeitoun D, Guerin P, Cormier B, Brochet E, Thibault H, Himbert D, Thivolet S, Leurent G, Bonnet G, Donal E, Piriou N, Piot C, Habib G, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Saint Etienne C, Leroux L, Gilard M, Samson G, Rioufol G, Maucort-Boulch D, Obadia JF; MITRA-FR Investigators. Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years. Eur J Heart Fail. 2019 Dec;21(12):1619-1627. doi: 10.1002/ejhf.1616. Epub 2019 Nov 18.

oa_colors: green other

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.

location_facility:
Hôpital Européen Georges Pompidou
Groupe Hospitalier La Salpétrière
Chu de Besancon
Chu de Bordeaux
Institut Mutualiste Montsouris
Aphp Hopital Bichat
Chu de Toulouse
CHRU La Cavale Blanche
Hôpital privé le Bois
Hôpital privé de Parly 2
Chu de Rennes
Centre Chirurgical Marie Lannelongue
Chu de Montpellier
CHRU La Milétrie
CHU d'Angers
APHP Hôpital Henri Mondor
CHU Rouen
CH Annecy Genevois
Groupement Hospitalier Est
Chu de Nantes
Institut Arnault Tzanck
Hôpital Saint-Joseph
Hôpital Nord
CHU de Grenoble
Centre Cardiologique du Nord
CHU Caen
Clinique Pasteur
Clinique Du Millenaire
Clinique du Tonkin
Hôpital privé Clairval
Hopital de La Timone
Clinique Cardiologique Saint Gatien
Hôpital Gabriel Montpied
Hôpital Pasteur
Chu de Lille
CHRU de Tours
Institut Hospitalier Jacques Cartier
Chu de Strasbourg
Chu de Nancy
Centre chirurgicale Ambroise Paré


acronym: APNEE REA

summary: Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each center will use the method of apnea test which it uses usually.

lead_sponsor: Poitiers University Hospital

location_facility:
La Roche sur Yon Hospital
Nice University Hospital
Rennes University hospital
Saintes Hospital
Limoges University Hospital
Nantes University Hospital
Tours University Hospital
Angoulême Hospital
Angers University Hospital
Poitiers University Hospital
Cochin University Hospital
Brest University Hospital
La Rochelle Hospital
Orléans Hospital
Toulon University Hospital
Bordeaux University Hospital
Sud Francilien Hospital


summary: STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer.

ReferenceCitation: Chibaudel B, Bonnetain F, Tournigand C, de Larauze MH, de Gramont A, Laurent-Puig P, Paget J, Hadengue A, Notelet D, Benetkiewicz M, Andre T, de Gramont A. STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer. BMC Cancer. 2015 Jul 4;15:496. doi: 10.1186/s12885-015-1503-7.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

repositories:
HAL
PubMed Central
serval.unil.ch

repositories_concat: HAL;PubMed Central;serval.unil.ch

sponsor_collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Adelaide & Meath Hospital Dublin ( AMNCH)

location_facility: Centre d'oncologie et de radiothérapie du Parc

title: Multi-Line Therapy Trial in Unresectable Wild-Type RAS Metastatic Colorectal Cancer. A GERCOR Randomized Open-label Phase III Study.

location_country: Ireland Israel France


acronym: ECLIPSE

lead_sponsor: Novartis Pharmaceuticals

summary: The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

title: An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.


title: Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock

acronym: CLOTILDE

summary: The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced by tissue reperfusion. These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock improves short-term and long term survival by reducing the size of the myocardial infarction. The hypothesis of this study is that the administration of Cyclosporin A to these patients, in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ failure associated with the cardiogenic shock and improve clinical outcome.

status: Withdrawn

lead_sponsor: Hospices Civils de Lyon

location_facility:
CH Pays d'Aix
Hopital Guillaume Et Rene Laennec
Chru de Tours
Chu de Nimes
Hôpital Gabriel Montpied
Chu de Rangueil
Hopital St Luc St Joseph
Aphp Hopital Bichat
Chu de Bordeaux
Chu Hopital A Michallon
Hopital Charles Nicolle
Centre Hospitalier de Pau
Nouvel Hôpital Civil
CHU Hopital Cardiologique Louis Pradel
Chu Hopital Du Bocage
Chu Arnaud de Villeneuve
Clinique de La Fourcade
Chu de Nancy Brabois


title: Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

acronym: PEP

summary: A standardized diagnostic strategy of pulmonary embolism will be applied to eligible patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed for 3 months.

lead_sponsor: University Hospital, Brest

location_facility:
Hôpital Européen Georges Pompidou
CHRU de Brest
CHU
CHU Clermont-Ferrand
Hôpital Nord
CH de Cornouaille Quimper
HIA


type: Other Grant/Funding Number

title: Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.

acronym: PRE-MUSICAL

summary:
The primary purpose of the protocol is to demonstrate that the use of music therapy may make it possible to discontinue at least one of neuroleptic treatment in patients with AD or related symptoms complicated by behavioral disorders such as agitation and aggressiveness evaluated using the Neuropsychiatric Inventory (NPI).

The study hypothesis is that music therapy may have a positive impact on patients with AD complicated by behavioral disorders by reducing the intensity of oppositional behaviour and aggressiveness and allowing a diminution of neuroleptic treatment.

ReferenceCitation: Aalten P, de Vugt ME, Jaspers N, Jolles J, Verhey FR. The course of neuropsychiatric symptoms in dementia. Part I: findings from the two-year longitudinal Maasbed study. Int J Geriatr Psychiatry. 2005 Jun;20(6):523-30. doi: 10.1002/gps.1316.

ReferenceCitation: Aldridge D. Music and Alzheimer's disease--assessment and therapy: discussion paper. J R Soc Med. 1993 Feb;86(2):93-5. No abstract available.

ReferenceCitation: Benoit M, Robert PH, Staccini P, Brocker P, Guerin O, Lechowski L, Vellas B; REAL.FR Group. One-year longitudinal evaluation of neuropsychiatric symptoms in Alzheimer's disease. The REAL.FR Study. J Nutr Health Aging. 2005;9(2):95-9.

ReferenceCitation: Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.

lead_sponsor: University Hospital, Toulouse

location_facility:
EHPAD La Villegiale
Residence Christian Bressole
Centre Hospitalier Gérard Marchant
University Hospital Toulouse
EHPAD KORIAN Grand Maison
EHPAD L'Oustal d'en Thibaud
EHPAD Les Quietudes

intervention_type: Behavioral


title: Prospective, Controlled Versus Placebo, Randomized, Double-blind Study, Evaluating the Value of Non-opioid Analgesic Combination (Based on Paracetamol, Nefopam, Ketoprofen) for Postoperative Analgesia.

acronym: OCTOPUS

summary:
The combination of different analgesic drugs and/or analgesia techniques is part of the standard management of postoperative analgesia. The analysis of the literature reveals a lack of comparison of the associations of non-opioid analgesic (NOA) with morphine for postoperative analgesia.

The objectives of this study are :

comparing the morphine sparing effect of different combination of 3 NOA (paracetamol, nefopam, ketoprofen) for postoperative analgesia.
determining whether the morphine-sparing effect is associated with or without a reduction in the incidence of morphine side effects.
evaluating the effects of NOA on postoperative hyperalgesia.

ReferenceCitation: Beloeil H, Albaladejo P, Sion A, Durand M, Martinez V, Lasocki S, Futier E, Verzili D, Minville V, Fessenmeyer C, Belbachir A, Aubrun F, Renault A, Bellissant E; OCTOPUS group. Multicentre, prospective, double-blind, randomised controlled clinical trial comparing different non-opioid analgesic combinations with morphine for postoperative analgesia: the OCTOPUS study. Br J Anaesth. 2019 Jun;122(6):e98-e106. doi: 10.1016/j.bja.2018.10.058. Epub 2018 Dec 29.

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

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

lead_sponsor: Rennes University Hospital

location_facility:
Frédéric Aubrun
Karim Asehnoune
Anissa Belbachir
Marc Raucoules
Dominique Fletcher
Xavier Capdevila
Pierre Albaladejo
Marc Beaussier
Karine Nouette-Gaulain
Jean-Marc Malinovsky
Hervé Bouaziz
Hawa Keita-Meyer
Jean-Xavier Mazoit
Emmanuel Marret
Marc Gentili
Marcel Chauvin
Vincent Minville
Jacques Ripart
Sébastien Bloc


acronym: ADDONIS

summary: To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.

title: Randomized, Open-label, SU-controlled Study of 24-week Duration to Compare Metformin/Vildagliptin + Basal Insulin Versus Metformin/SU + Basal Insulin in T2DM Patients Starting Basal Insulin After Failing Metformin/SU


acronym: MODEL

summary:
For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy).

There is two types of maintenance :

continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression.
switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.

Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival.

The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.

ReferenceCitation: Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducolone A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.

ReferenceCitation: Quoix E, Audigier-Valette C, Lavole A, Molinier O, Westeel V, Barlesi F, Le Treut J, Pichon E, Dauba J, Otto J, Moreau L, Madelaine J, Dumont P, Margery J, Debieuvre D, Renault PA, Pujol JL, Langlais A, Morin F, Moro-Sibilot D, Souquet PJ. Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer: IFCT-1201 MODEL trial. Eur J Cancer. 2020 Oct;138:193-201. doi: 10.1016/j.ejca.2020.07.034. Epub 2020 Sep 6.

oa_host_type: closed

location_facility: APHP - CHU Avicenne - Oncologie Medicale

location_facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

title: Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.


acronym: AMA

summary: The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer.

ReferenceCitation: Bonnefoi H, Grellety T, Tredan O, Saghatchian M, Dalenc F, Mailliez A, L'Haridon T, Cottu P, Abadie-Lacourtoisie S, You B, Mousseau M, Dauba J, Del Piano F, Desmoulins I, Coussy F, Madranges N, Grenier J, Bidard FC, Proudhon C, MacGrogan G, Orsini C, Pulido M, Goncalves A. A phase II trial of abiraterone acetate plus prednisone in patients with triple-negative androgen receptor positive locally advanced or metastatic breast cancer (UCBG 12-1). Ann Oncol. 2016 May;27(5):812-8. doi: 10.1093/annonc/mdw067. Epub 2016 Feb 18.

location_facility: Institut Curie - Hôpital Claudius Regaud

title: A Phase II Trial Evaluating the Activity of Abiraterone Acetate Plus Prednisone in Patients With a Molecular Apocrine HER2-negative Locally Advanced or Metastatic Breast Cancer


title: Retrospective Observational Study Of Patients Previously Treated With Tigecycline In ICU And Included In The Previous French Prospective Observational Study

summary: The goal of this retrospective observational study is to collect only status survival data 30 days after the last dose of treatment of patients included in the initial protocol WYETH 3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.

lead_sponsor: Pfizer


acronym: PERNETTA

lead_sponsor: Swiss Group for Clinical Cancer Research

summary: In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.

location_facility: Kantonsspital Frauenfeld / Brustzentrum Thurgau

location_facility: Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

location_facility: Antoni van Leeuwenhoek / Slotervaart hospital

location_facility: Centre Hospitalier Universitaire Vaudois CHUV

location_facility: Centre Hospitalier de Perpignan - Hopital Saint Jean

location_facility: Fondation Hopital Ambroise Pare - Hopital Europeen

location_facility: Hopital Michallon - Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier - Site Hopital du Scorff

location_facility: Zentrum fuer Tumordiagnostik und Praevention

location_facility: Leiden_Leids Universitair Medisch Centrum (LUMC)

location_facility: Hopitaux Universitaire de Strasbourg - Hopital Civil

location_facility: Institut Regional du Cancer Montpellier Val d'Aurelle

title: A Randomized Phase II Trial of Pertuzumab in Combination With Trastuzumab With or Without Chemotherapy, Both Followed by T-DM1 in Case of Progression, in Patients With HER2-positive Metastatic Breast Cancer

location_country: Germany Netherlands Switzerland France


title: Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care

acronym: Bakri

summary:
This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm.

The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.

ReferenceCitation: Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

oa_host_type: repository

unpaywall_oa_status: green

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: APHP - Centre Hospitalier Universitaire de Bicêtre


title: Comparative Analysis of Two Therapeutic Strategies: "Early Switch" Versus "Therapeutic Intensification" in Patients With Spondyloarthritis Treated With Anti-tnf Biologics, in Case of Secondary Treatment Failure Suspicion.

acronym: STRADA

summary:
The objective of the study is to evaluate two therapeutic strategies: "early switch" or "therapeutic intensification" in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of ASDAS and positivity to ADAb.

Patients and Methods:

Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or adalimumab will be included if their ADAb dosage is positive, and they will be randomized (1:1) in two groups : "early switch" where treatment will be change to another anti-TNF, or "therapeutic intensification" where interval between two injections will be shortened. Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24 weeks. Principal outcome will be the variation of ASDAS between baseline and end of the study. Number of patients to be included has been determined statistically from a preliminary study (power >98% for ASDAS variation of 20% on week 24).

Expected results:

On week 24, we expect a better response and a greater proportion of patients in remission in the "early switch" arm compare to the "therapeutic intensification" arm.

lead_sponsor: University Hospital, Rouen

location_facility:
UH Caen
Dieppe Hospital
UH Amiens
Elbeuf Hospital
UH Rouen
UH Lille
Le Havre Hospital


type: Registry Identifier

title: An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Chemotherapy With Gemcitabine and Cisplatin for the Treatment of Intra-hepatic Cholangiocarcinoma, First Line.

acronym: MispheC

summary: The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.

lead_sponsor: Center Eugene Marquis

location_facility:
CHU- Hotel Dieu
Hôpital Henri Mondor
Hôpital Beaujon - Service de Chirurgie
Centre Eugene Marquis
CHU Poitiers
Hôpital saint-Eloi
CHU Nancy - Hôpital Brabois


title: A Multicenter Study Assessing the Prevalence of Co-addictions in Subjects Receiving Maintenance Treatment for Opiate Dependence. Determination of Clinical and Pharmacological Profil.

acronym: OPAL

summary:
The aim of this study is to determine the current prevalence of co-addictions, including problem/pathological gambling, in patients receiving Opiate Substitution Treatment (OST), and to then compare patients receiving OST with or without a co-addiction (excluding tobacco dependence) in order to determine their clinical profile.

In addition, an ancillary study to be carried out only among those patients receiving methadone, will aim to etablish whether a low plasma concentration of methadone, on the one hand, and an ultrarapid metabolizer genetic profile, on the other, are the characteristics most commonly associated with the presence of co-addictions. This will allow us to complete patient's pharmacological characterization.

ReferenceCitation: Bouju G, Hardouin JB, Boutin C, Gorwood P, Le Bourvellec JD, Feuillet F, Venisse JL, Grall-Bronnec M. A shorter and multidimensional version of the Gambling Attitudes and Beliefs Survey (GABS-23). J Gambl Stud. 2014 Jun;30(2):349-67. doi: 10.1007/s10899-012-9356-3.

ReferenceCitation: Grall-Bronnec M, Wainstein L, Feuillet F, Bouju G, Rocher B, Venisse JL, Sebille-Rivain V. Clinical profiles as a function of level and type of impulsivity in a sample group of at-risk and pathological gamblers seeking treatment. J Gambl Stud. 2012 Jun;28(2):239-52. doi: 10.1007/s10899-011-9258-9.

ReferenceCitation: Grall-Bronnec M, Wainstein L, Augy J, Bouju G, Feuillet F, Venisse JL, Sebille-Rivain V. Attention deficit hyperactivity disorder among pathological and at-risk gamblers seeking treatment: a hidden disorder. Eur Addict Res. 2011;17(5):231-40. doi: 10.1159/000328628. Epub 2011 Jun 7.

ReferenceCitation: Guillou Landreat M, Dany A, Challet Bouju G, Laforgue EJ, Cholet J, Leboucher J, Hardouin JB; OPAL Group; Victorri Vigneau C, Grall Bronnec M. How do people who use drugs receiving Opioid Medication Therapy perceive their treatment ? A multicentre study. Harm Reduct J. 2022 Mar 28;19(1):31. doi: 10.1186/s12954-022-00608-6.

ReferenceCitation: Guillou-Landreat M, Dany A, Challet-Bouju G, Laforgue E, Leboucher J, Benoit Hardouin J, Victorri-Vigneau C, Grall-Bronnec M. What Differs between Patients under Methadone and under Buprenorphine for Opioid Use Disorder (OUD) in Daily Clinical Practice in France? A Short Report. Int J Environ Res Public Health. 2021 Feb 3;18(4):1425. doi: 10.3390/ijerph18041425.

repository_institution: MDPI AG - MDPI

repositories:
HAL
PubMed Central
mdpi.com

repositories_concat: HAL;PubMed Central;mdpi.com

publisher_dissemination: MDPI

lead_sponsor: Nantes University Hospital

location_facility: Réseau toxicomanie de la région nantaise


title: Endomysial Fibrosis, Muscular Inflammatory Response and Calcium Homeostasis Dysfunction : Potential Links and Targeted Pharmacotherapy in Duchenne Muscular Dystrophy (DMD).

summary:
Duchenne muscular dystrophy (DMD) is the most common and devastating form of muscular dystrophy, caused by an X-chromosome gene mutation resulting in the absence of the protein dystrophin. Gene therapy by exon skipping or stop codon read-through and cell therapy are at the stage of clinical assays with very promising results. Nevertheless, they will not allow a complete cure of DMD patients and they will concern only specific types of mutations. It is therefore crucial to develop other therapeutic strategies related to the natural history of the disease and targeted not on the dystrophin itself, but on the consequences of its absence.

Another crucial pathophysiological pathway in DMD is muscle cell calcium homeostasis, particularly via the ryanodine recepteur (RyR1).

Our study focus on the relationship between endomysial fibrosis, abnormal inflammation response and calcium homeostasis dysfunction which are not entirely established in DMD.

The identification of the biological mechanisms that play a role in the severity of the phenotype, particularly endomysial fibrosis, should allow the development of targeted pharmacotherapy as a complementary strategy for the future treatment of DMD.

lead_sponsor: University Hospital, Montpellier

location_facility:
Montpellier University Hospital
UH Toulouse
UH Bordeaux
UH Reims
UH Lille
UH Saint Etienne
Necker Hospital


summary:
Patients patients enrolled in this study have a Lymphoma caused by EBV (after bone marrow transplantation, organ transplantation or patient immunodeficient.

They will receive one to three injections of allogenic CTL specific EBV.

The purpose of this study is to ensure that these injections can not cause a GVH and to study what the side effects are and to see whether this therapy might help patients with Lymphoma.

Immunological monitoring will also be studied.

ReferenceCitation: Gallot G, Vollant S, Saiagh S, Clemenceau B, Vivien R, Cerato E, Bignon JD, Ferrand C, Jaccard A, Vigouroux S, Choquet S, Dalle JH, Frachon I, Bruno B, Mothy M, Mechinaud F, Leblond V, Milpied N, Vie H. T-cell therapy using a bank of EBV-specific cytotoxic T cells: lessons from a phase I/II feasibility and safety study. J Immunother. 2014 Apr;37(3):170-9. doi: 10.1097/CJI.0000000000000031.

location_facility:
CHU de Lille
CHU de Limoges
CHU de Brest
CHU de Nantes
CHU de Bordeaux
Hopital Pitié Salpétrière
Hôpital Necker


title: Active Early Individualized Psychosocial Accompaniment to Facilitate the Return to Employment of Women With Breast Cancer

acronym: APAPI

summary: The purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
University Hospital, Lille

location_facility:
Centre Pierre Curie
Centre Hospitalier
Centre Léonard de Vinci
Hôpital Privé de Villeneuve d'Ascq
Centre Oscar Lambret
Centre Marie Curie
Nouvelle Clinique des Dentellières


acronym: Néofirinox

lead_sponsor: UNICANCER

summary: National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.

ReferenceCitation: Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

location_facility: Institut de Cancérologie de Franche Comté

location_facility: Centre hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier de la Réunion - Site du GHSR

title: Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

ipd_sharing: Yes


lead_sponsor: National Cancer Institute, Naples

summary:
Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.

ReferenceCitation: Pignata S, Lorusso D, Joly F, Gallo C, Colombo N, Sessa C, Bamias A, Salutari V, Selle F, Frezzini S, De Giorgi U, Pautier P, Bologna A, Orditura M, Dubot C, Gadducci A, Mammoliti S, Ray-Coquard I, Zafarana E, Breda E, Favier L, Ardizzoia A, Cinieri S, Largillier R, Sambataro D, Guardiola E, Lauria R, Pisano C, Raspagliesi F, Scambia G, Daniele G, Perrone F; MITO16b/MANGO-OV2/ENGOT-ov17 Investigators. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):267-276. doi: 10.1016/S1470-2045(20)30637-9.

ReferenceCitation: Arend R, Westin SN, Coleman RL. Decision analysis for secondline maintenance treatment of platinum sensitive recurrent ovarian cancer: a review. Int J Gynecol Cancer. 2020 May;30(5):684-694. doi: 10.1136/ijgc-2019-001041. Epub 2020 Feb 19.

sponsor_collaborators: Mario Negri Institute for Pharmacological Research

location_facility: Centre de Radiothèrapie - Clinique Sainte-Anne

location_facility: Zentrum fùr Onkologie/ Hamat. und Transf

location_facility: Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

location_facility: Fondazione del Piemonte per l'Oncologia IRCCS

location_facility: Hôpital Inter Armées de Begin (HIA Begin),

location_facility: Ospedale S. Maria delle Croci AUSL di Ravenna

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

location_facility: A.O. di Udine S. Maria della Misericordia

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Ospedale S. Giovanni Calibita Fatebenefratelli

location_facility: Istituto Romagnolo per lo Studio e la Cura dei Tumori

title: Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line

location_country: Italy Switzerland Greece Monaco France