title: Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis

summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.

ReferenceCitation: Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prisé E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

family: Campillo-Gimenez

full_name: Boris Campillo-Gimenez

given: Boris

family: Buscail

full_name: Camille Buscail

given: Camille

family: Zekri

full_name: Oussama Zekri

given: Oussama

family: Laguerre

full_name: Brigitte Laguerre

given: Brigitte

family: Le Prisé

full_name: Elisabeth Le Prisé

given: Elisabeth

family: De Crevoisier

full_name: Renaud De Crevoisier

given: Renaud

family: Cuggia

full_name: Marc Cuggia

given: Marc

journal_name: Trials

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Hopital d'Instruction des Armees du Val de Grace

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

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

location_facility: Centre Hospital Regional Universitaire de Limoges

intervention_type: Radiation


title: Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers

summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Gravis G, Fizazi K, Joly F, et al.: Safety results from a phase III trial comparing androgen-deprivation therapy (ADT) plus docetaxel versus ADT alone in hormone-naïve metastatic prostate cancer (GETUG-AFU 15/0403). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-43, 2010.

ReferenceCitation: Gravis G, Fizazi K, Joly F, et al.: Randomized phase III study comparing docetaxel and androgen deprivation therapy (ADT) versus ADT alone in androgen dependent metastatic prostate cancer (GETUG-15/0403): a French national muticentric study sponsored by the French Federation des Centres. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-161, 2007.

ReferenceType: derived

sequence: first

sequence: additional

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

title: Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials

ReferenceCitation: Trump DL. Commentary on "Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial." Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Théodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M, Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France. Lancet Oncol 2013;14(2):149-58 [Epub 2013 Jan 8]. Urol Oncol. 2013 Nov;31(8):1845. doi: 10.1016/j.urolonc.2013.08.011.

family: Trump

full_name: Donald L. Trump

given: Donald L.

journal_name: Urologic Oncology: Seminars and Original Investigations

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Commentary on “Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): A randomised, open-label, phase 3 trial.” Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Théodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M, Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France.

ReferenceCitation: Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Théodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):149-58. doi: 10.1016/S1470-2045(12)70560-0. Epub 2013 Jan 8.

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Joly

full_name: Florence Joly

given: Florence

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

family: Priou

full_name: Franck Priou

given: Franck

ReferenceCitation: Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35. Review.

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

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

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

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer.

status: Unknown status

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre d'Oncologie et de Radiotherapie du Parc

location_facility: Clinique Medico Chirurgicale Teissier Groupe

location_facility: Polyclinique Du Parc Centre Maurice Tubiana

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Centre d'Oncologie et de Radiotherapie de Chaumont le Bois

lead_sponsor_type: industriel

status_simplified: Unknown


title: Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the stomach.

location_facility: Centre Hospital General Robert Ballanger

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Hopital d'Instruction des Armes Sainte-Anne

intervention_type: Drug


title: Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

ReferenceType: background

ReferenceCitation: Huguet F, André T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31.

ReferenceCitation: Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16.


type: Other Identifier

title: Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.

design_allocation: Non-Randomized

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Procedure

status_simplified: Completed


title: Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse

summary:
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Fizazi K, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houedé N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Fléchon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Lagrange JL, Chinet-Charrot P, Linassier C, Deplanque G, Beuzeboc P, Geneve J, Davin JL, Tournay E, Culine S. A phase III trial of docetaxel-estramustine in high-risk localised prostate cancer: a planned analysis of response, toxicity and quality of life in the GETUG 12 trial. Eur J Cancer. 2012 Jan;48(2):209-17. doi: 10.1016/j.ejca.2011.10.015. Epub 2011 Nov 24.

family: Lesaunier

full_name: Francois Lesaunier

given: Francois

family: Delva

full_name: Remy Delva

given: Remy

full_name: Gwenaëlle Gravis

given: Gwenaëlle

family: Rolland

full_name: Frederic Rolland

given: Frederic

full_name: Frank Priou

given: Frank

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Houedé

full_name: Nadine Houedé

given: Nadine

family: Mourey

full_name: Loïc Mourey

given: Loïc

family: Theodore

full_name: Christine Theodore

given: Christine

family: Krakowski

full_name: Ivan Krakowski

given: Ivan

family: Berdah

full_name: Jean-François Berdah

given: Jean-François

family: Baciuchka

full_name: Marjorie Baciuchka

given: Marjorie

family: Fléchon

full_name: Aude Fléchon

given: Aude

family: Ravaud

full_name: Alain Ravaud

given: Alain

family: Cojean-Zelek

full_name: Isabelle Cojean-Zelek

given: Isabelle

family: Labourey

full_name: Jean-Luc Labourey

given: Jean-Luc

family: Lagrange

full_name: Jean-Léon Lagrange

given: Jean-Léon

family: Chinet-Charrot

full_name: Paule Chinet-Charrot

given: Paule

family: Linassier

full_name: Claude Linassier

given: Claude

family: Deplanque

full_name: Gaël Deplanque

given: Gaël

title: A phase III trial of docetaxel–estramustine in high-risk localised prostate cancer: A planned analysis of response, toxicity and quality of life in the GETUG 12 trial

ReferenceCitation: Fizazi K, Lesaunier F, Delva R, et al.: A phase III trial of docetaxel-estramustine in high-risk localized prostate cancer (GETUG 12 trial): design, tolerance, response, and quality of life (QOL). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-7, 2010.

ReferenceCitation: Fizazi K, Gravis G, Culine S: The GETUG 12 trial, a phase III randomized trial of docetaxel-estramustine in high-risk localized prostate cancer: clinical design and current status. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-153, 2006.

ReferenceCitation: Fizazi K, Faivre L, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Fléchon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Chinet-Charrot P, Legouffe E, Lagrange JL, Linassier C, Deplanque G, Beuzeboc P, Davin JL, Martin AL, Habibian M, Laplanche A, Culine S. Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial. Lancet Oncol. 2015 Jul;16(7):787-94. doi: 10.1016/S1470-2045(15)00011-X. Epub 2015 May 28.

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

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

location_facility: Centre Hospital Regional Universitaire de Limoges


title: Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer.

ReferenceCitation: Kerbrat P, Desmoulins I, Roca L, Levy C, Lortholary A, Marre A, Delva R, Rios M, Viens P, Brain É, Serin D, Edel M, Debled M, Campone M, Mourret-Reynier MA, Bachelot T, Foucher-Goudier MJ, Asselain B, Lemonnier J, Martin AL, Roché H. Optimal duration of adjuvant chemotherapy for high-risk node-negative (N-) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106). Eur J Cancer. 2017 Jul;79:166-175. doi: 10.1016/j.ejca.2017.03.004. Epub 2017 May 11.

family: Kerbrat

full_name: Pierre Kerbrat

given: Pierre

family: Desmoulins

full_name: Isabelle Desmoulins

family: Roca

full_name: Lise Roca

given: Lise

family: Levy

full_name: Christelle Levy

given: Christelle

family: Lortholary

full_name: Alain Lortholary

family: Marre

full_name: Alain Marre

family: Delva

full_name: Rémy Delva

given: Rémy

family: Rios

full_name: Maria Rios

given: Maria

family: Viens

full_name: Patrice Viens

given: Patrice

family: Brain

full_name: Étienne Brain

given: Étienne

family: Serin

full_name: Daniel Serin

given: Daniel

family: Edel

full_name: Magali Edel

given: Magali

family: Debled

full_name: Marc Debled

given: Marc

family: Campone

full_name: Mario Campone

given: Mario

family: Mourret-Reynier

full_name: Marie-Ange Mourret-Reynier

given: Marie-Ange

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Foucher-Goudier

full_name: Marie-Josèphe Foucher-Goudier

given: Marie-Josèphe

family: Asselain

full_name: Bernard Asselain

given: Bernard

family: Lemonnier

full_name: Jérôme Lemonnier

given: Jérôme

family: Martin

full_name: Anne-Laure Martin

given: Anne-Laure

family: Roché

full_name: Henri Roché

given: Henri

journal_name: European Journal of Cancer

title: Optimal duration of adjuvant chemotherapy for high-risk node-negative (N–) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106)

location_facility: Centre Hospitalier General Andre Boulloche

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron


title: Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).

ReferenceCitation: Mancini J, Genre D, Dalenc F, Maylevin F, Martin AL, Viens P, Julian-Reynier C. Transparency in the presentation of trial results may not increase patients' trust in medical researchers. Clin Trials. 2012 Feb;9(1):90-3. doi: 10.1177/1740774511427063. Epub 2011 Nov 2.

ReferenceCitation: Roché H, Allouache D, Romieu G, et al.: Five-year analysis of the FNCLCC-PACS04 trial: FEC100 vs ED75 for the adjuvant treatment of node positive breast cancer. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-602, 2009.

ReferenceCitation: Spielmann M, Roché H, Delozier T, Canon JL, Romieu G, Bourgeois H, Extra JM, Serin D, Kerbrat P, Machiels JP, Lortholary A, Orfeuvre H, Campone M, Hardy-Bessard AC, Coudert B, Maerevoet M, Piot G, Kramar A, Martin AL, Penault-Llorca F. Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol. 2009 Dec 20;27(36):6129-34. doi: 10.1200/JCO.2009.23.0946. Epub 2009 Nov 16.

name: From the Department of Medicine, Institut Gustave Roussy, Villejuif; Department of Medicine, Institut Claudius Régaud, Toulouse; Department of Medicine, Centre François Baclesse, Caen; Department of Medicines and Biostatistics, Centre Val d'Aurelle, Montpellier; Department of Medicine, Centre Hospitalo-Universitaire, Poitiers; Department of Medicine, Institut Curie; Fédération Nationale des Centres de Lutte Contre le Cancer, Paris, France; Department of Medicine, Institut Sainte-Catherine, Avignon;...

family: Spielmann

full_name: Marc Spielmann

family: Delozier

full_name: Thierry Delozier

given: Thierry

family: Canon

full_name: Jean-Luc Canon

given: Jean-Luc

family: Romieu

full_name: Gilles Romieu

given: Gilles

family: Bourgeois

full_name: Hugues Bourgeois

given: Hugues

family: Extra

full_name: Jean-Marc Extra

given: Jean-Marc

family: Kerbrat

full_name: Pierre Kerbrat

given: Pierre

family: Machiels

full_name: Jean-Pascal Machiels

given: Jean-Pascal

family: Lortholary

full_name: Alain Lortholary

given: Alain

family: Orfeuvre

full_name: Hubert Orfeuvre

given: Hubert

family: Hardy-Bessard

full_name: Anne-Claire Hardy-Bessard

given: Anne-Claire

family: Coudert

full_name: Bruno Coudert

given: Bruno

family: Maerevoet

full_name: Marie Maerevoet

given: Marie

family: Piot

full_name: Gilles Piot

family: Kramar

full_name: Andrew Kramar

given: Andrew

family: Penault-Llorca

full_name: Frédérique Penault-Llorca

given: Frédérique

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Trastuzumab for Patients With Axillary-Node–Positive Breast Cancer: Results of the FNCLCC-PACS 04 Trial

ReferenceCitation: Spielmann M, Roché H, Humblet Y, et al.: 3-year follow-up of trastuzumab following adjuvant chemotherapy in node positive HER2-positive breast cancer patients: results of the PACS-04 trial. [Abstract] Breast Cancer Res Treat 106 (1): A-72, S19, 2007.

ReferenceCitation: Spielmann M, Roché H, Delozier T, et al.: Safety analysis from PACS 04--a phase III trial comparing 6 cycles of FEC100 with 6 cycles of ET75 for node-positive early breast cancer patients, followed by sequential trastuzumab in HER2+patients: preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-632, 2006.

ReferenceCitation: O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors ≤ 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.

name: Ciara C. O'Sullivan and Jo Anne Zujewski, National Cancer Institute, Bethesda, MD; Ian Bradbury, Christine Campbell, and Eileen Holmes, Frontier Science, Inverness-shire, Scotland; Marc Spielmann and Suzette Delaloge, Institut de Cancérologie Gustave Roussy, Villejuif, France; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Heikki Joensuu, Helsinki University Hospital and University of Helsinki, Helsinki, Finland; Joseph P. Costantino and Priya Rastogi, University of Pittsburgh, Pittsburgh, PA; Dimitrios...

family: O'Sullivan

full_name: Ciara C. O'Sullivan

title: Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer and Tumors ≤ 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials

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

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


title: Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.

status: Terminated


type: Registry Identifier

title: Conformational, Curative Ratiotherapy For Prostate Cancer (NO, N-): Phase III Multicenter Study Of The Contribution To Survival Without Clinical Or Biological Change With A Dose Variation Of 15% (80 Gy VS 70 Gy)

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer.

ReferenceCitation: Beckendorf V, Guerif S, Le Prisé E, Cosset JM, Bougnoux A, Chauvet B, Salem N, Chapet O, Bourdain S, Bachaud JM, Maingon P, Hannoun-Levi JM, Malissard L, Simon JM, Pommier P, Hay M, Dubray B, Lagrange JL, Luporsi E, Bey P. 70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial. Int J Radiat Oncol Biol Phys. 2011 Jul 15;80(4):1056-63. doi: 10.1016/j.ijrobp.2010.03.049. Epub 2010 Dec 14.

family: Beckendorf

full_name: Véronique Beckendorf

given: Véronique

family: Guerif

full_name: Stéphane Guerif

given: Stéphane

family: Le Prisé

full_name: Elisabeth Le Prisé

given: Elisabeth

family: Cosset

full_name: Jean-Marc Cosset

family: Bougnoux

full_name: Agnes Bougnoux

given: Agnes

family: Chauvet

full_name: Bruno Chauvet

family: Salem

full_name: Naji Salem

given: Naji

family: Chapet

full_name: Olivier Chapet

given: Olivier

family: Bourdain

full_name: Sylvain Bourdain

given: Sylvain

family: Bachaud

full_name: Jean-Marc Bachaud

family: Maingon

full_name: Philippe Maingon

given: Philippe

family: Hannoun-Levi

full_name: Jean-Michel Hannoun-Levi

given: Jean-Michel

family: Malissard

full_name: Luc Malissard

given: Luc

family: Simon

full_name: Jean-Marc Simon

family: Pommier

full_name: Pascal Pommier

given: Pascal

family: Hay

full_name: Men Hay

given: Men

family: Dubray

full_name: Bernard Dubray

given: Bernard

family: Lagrange

full_name: Jean-Léon Lagrange

given: Jean-Léon

family: Luporsi

full_name: Elisabeth Luporsi

family: Bey

full_name: Pierre Bey

journal_name: International Journal of Radiation Oncology*Biology*Physics

title: 70 Gy Versus 80 Gy in Localized Prostate Cancer: 5-Year Results of GETUG 06 Randomized Trial

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Hopital Jules Courmont - Centre Hospitalier Lyon Sud


title: Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.

ReferenceCitation: André T, Noirclerc M, Hammel P, Meckenstock R, Landi B, Cattan S, Selle F, Codoul JF, Guerrier-Parmentier B, Mokhtar R, Louvet C; GERCOR. Phase II study of leucovorin, 5-fluorouracil and gemcitabine for locally advanced and metastatic pancreatic cancer (FOLFUGEM 2). Gastroenterol Clin Biol. 2004 Aug-Sep;28(8-9):645-50. Review.

location_country: Luxembourg France

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

location_facility: L'Institut Mutualiste Montsouris Jourdan

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud


title: Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.

PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.

location_facility: Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie


title: Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.

location_facility: Hopital Desgenettes - Service de Medecine Interne


title: First Line Treatment of Stage IIIb/IV Non Small Cell (NSC) Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cisplatin with gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

location_facility: Centre Hospitalier Departmental Felix Guyon


title: Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.

ReferenceCitation: Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouché O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Apr;20(4):674-80. doi: 10.1093/annonc/mdn680. Epub 2009 Jan 29.

family: Ychou

full_name: M. Ychou

given: M.

family: Raoul

full_name: J.-L. Raoul

family: Douillard

full_name: J.-Y. Douillard

family: Gourgou-Bourgade

full_name: S. Gourgou-Bourgade

given: S.

family: Bugat

full_name: R. Bugat

given: R.

family: Mineur

full_name: L. Mineur

given: L.

family: Viret

full_name: F. Viret

given: F.

family: Becouarn

full_name: Y. Becouarn

given: Y.

family: Bouché

full_name: O. Bouché

given: O.

family: Gamelin

full_name: E. Gamelin

given: E.

family: Ducreux

full_name: M. Ducreux

family: Conroy

full_name: T. Conroy

given: T.

family: Seitz

full_name: J.-F. Seitz

family: Bedenne

full_name: L. Bedenne

family: Kramar

full_name: A. Kramar

given: A.

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Côté JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007 Jun 1;13(11):3269-75. Epub 2007 May 17.

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier de Bourgoin - Jallieu


title: Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have small cell lung cancer.

enrollment_type: Anticipated


title: Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have germ cell tumors that have not responded to previous chemotherapy.

location_facility: Hopital d'Instruction des Armees du Val de Grace


title: Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.

ReferenceCitation: Tournier-Rangeard L, Mercier M, Peiffert D, Gerard JP, Romestaing P, Lemanski C, Mirabel X, Pommier P, Denis B. Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03). Radiother Oncol. 2008 Jun;87(3):391-7. doi: 10.1016/j.radonc.2007.12.004. Epub 2008 Jan 11.

family: Tournier-Rangeard

full_name: Laetitia Tournier-Rangeard

given: Laetitia

family: Mercier

full_name: Mariette Mercier

given: Mariette

family: Peiffert

full_name: Didier Peiffert

given: Didier

family: Gerard

full_name: Jean-Pierre Gerard

given: Jean-Pierre

family: Romestaing

full_name: Pascale Romestaing

given: Pascale

family: Lemanski

full_name: Claire Lemanski

given: Claire

family: Mirabel

full_name: Xavier Mirabel

given: Xavier

family: Pommier

full_name: Pascal Pommier

family: Denis

full_name: Bernard Denis

journal_name: Radiotherapy and Oncology

title: Radiochemotherapy of locally advanced anal canal carcinoma: Prospective assessment of early impact on the quality of life (randomized trial ACCORD 03)

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Centre Hospitalier General de Saint Nazaire


title: Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.

ReferenceCitation: Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, Pabot du Chatelard PM, Bernier V, Voirin N, Perol D, Carrie C. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007 Dec 1;25(34):5366-73.

ReferenceCitation: Pommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005.

location_facility: Clinique de la Sauvegarde - Clinique Jeanne D'Arc

location_facility: Centre Hospital Regional Universitaire de Limoges


title: A RANDOMIZED, MULTI-CENTRE PHASE III TRIAL TO EVALUATE THE ROLE OF INTENSIFIED THERAPY WITH AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS IN ADVANCED OR METASTATIC BREAST CANCER RESPONDING TO INDUCTION CHEMOTHERAPY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. It is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more effective than standard therapy for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women who have locally recurrent or metastatic breast cancer.

ReferenceCitation: Biron P, Durand M, Roché H, Delozier T, Battista C, Fargeot P, Spaeth D, Bachelot T, Poiget E, Monnot F, Tanguy ML, Curé H. Pegase 03: a prospective randomized phase III trial of FEC with or without high-dose thiotepa, cyclophosphamide and autologous stem cell transplantation in first-line treatment of metastatic breast cancer. Bone Marrow Transplant. 2008 Mar;41(6):555-62. Epub 2007 Nov 26.

ReferenceCitation: Biron P, Durand M, Roche H, et al.: High dose thiotepa (TTP), cyclophosphamide (CPM) and stem cell transplantation after 4 FEC 100 compared with 4 FEC alone allowed a better disease free survival but the same overall survival in first line chemotherapy for metastatic breast cancer: results of the PEGASE 03 French protocole. [Abstract] Proceedings of the American Society of Clinical Oncology A-167, 2002.

location_facility: Federation Nationale des Centres de Lutte Contre le Cancer

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

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


title: PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for small cell lung cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy using two different doses of cyclophosphamide followed by alternating chemotherapy and radiation therapy in treating patients with small cell lung cancer.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Centre Hospitalier Sud Francilien - Site Corbeil

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

lead_sponsor_type: academique


title: Auvergne-Rhône-Alpes-Limousin Research Database for Still's Diseases in Children and Adults

acronym: AURAL-STILL

summary:
Adult-Onset Still's disease is a polygenic autoinflammatory disease of unknown etiology. The autoinflammatory character individualizes it from autoimmune autoantibody diseases. Clinically, it results in the classic triad associating hectic fever, evanescent rash and arthritis. Although it is benign in the vast majority of cases, life-threatening complications can occur. By definition, the disease affects adults over 16 years of age, however most experts now agree that the adult form and the pediatric form belong to a pathological continuum: Still's disease. In the absence of a specific biomarker, the diagnosis is still based on clinical and biological criteria, after the exclusion of differential diagnoses.

Classically, three evolutionary profiles of Adult-Onset Still's disease are individualized, depending on the evolution of symptoms over time:

a monocyclic systemic form (30% of cases) characterized by clear systemic symptoms and in the foreground compared to the articular signs. This form evolves over several weeks to several months (on average 9 months), without exceeding a year. By definition, there is no recurrence;
a polycyclic systemic form (30% of cases) defined by the occurrence of at least two systemic or joint episodes, separated by clinical remission intervals greater than two months, or even several years. The symptoms of relapses are not always the same as the initial symptoms. The number and severity of relapses is unpredictable and varies widely from patient to patient, but symptoms tend to become less severe over time.
a chronic form, with predominant joint involvement (40%), resembling seronegative rheumatoid arthritis. Systemic signs are present during the first outbreaks of the disease. Subsequently, rheumatoid arthritis evolves on its own and one can see joint destruction or conversely ankylosing developments such as the classic bilateral, non-erosive fusing carpitis.

There are reasons to believe that the evolving profile of patients has changed since the emergence and generalization of biotherapies. Furthermore, no prognostic factor for the progression of Adult-Onset Still's disease has been found so far. The differences between pediatric and adult forms need to be confirmed and becoming pediatric forms in adulthood is poorly described.

The objective of this study is to set up a regional research database (Auvergne-Rhône-Alpes-Limousin) in order to describe the characteristics, treatment and evolution of patients with Still's disease.

status: Recruiting

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

ipd_sharing_description: The individual participant data will not be shared

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Edouard Herriot

intervention_type: Other

status_simplified: Ongoing


title: STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP

acronym: Deeper

summary:
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients. Due to its transmural nature (involvement of the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula) which requires intestinal resection in approximately half of patients during their follow-up. The long-term goal for patients is to maintain a normal life, that is, without symptoms and without intestinal destruction. For this, the short and medium term therapeutic objectives have evolved in recent years. Clinical remission is not a sufficient goal since it has failed to alter the natural history of the disease. The current objective to be achieved is the combination of clinical remission and endoscopic mucosal healing since it is associated with a reduced risk of progression (reappearance of symptoms, hospitalization, intestinal resection). Fecal calprotectin, better accepted than colonoscopy, is a non-invasive biomarker of endoscopic inflammatory activity in CD. The CALM study recently showed that close follow-up with clinical and biological evaluation (assays of CRP and fecal calprotectin), called "tight control", associated with therapeutic intensification in the absence of clinical or biological remission, was associated with a better rate of endoscopic mucosal healing at 1 year than follow-up based solely on symptoms. Thus, the "CALM" strategy is considered to be the current benchmark.

Transmural healing evaluated by MRI is also a promising objective associated with a reduced risk of progression (reappearance of symptoms, hospitalization, bowel resection). In addition, it could prevent intestinal destruction. A recent study by our team suggested that calprotectin (mucosal assessment) and MRI (transmural assessment) may be complementary and be a better therapeutic goal. We hypothesize that a "CALM + MRI" strategy concomitantly targeting transmural healing would be superior to the "CALM" strategy alone in maintaining clinical remission without corticosteroids in patients with CD treated with biotherapies.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Prevention

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Nancy University hospital
Montpellier University hospital
Rennes University Hospital
Chambery Hospital
Amiens university hospital
Aurillac Hospital
Bayonne hospital
Grenoble University Hospital
Bordeaux university hospital
Nice University hospital
Clermont-Ferrand University hospital
LILLE university hospital
Thiers Hospital
Issoire Hospital
Montluçon Hospital
Saint Etienne University Hospital
Lyon Hospital, Hospices civils de Lyon


title: Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation'). A Prospectvie Cohort.

summary: This is a prospective, multicentric, non comparative study aiming to evaluate the clinical and virological evolution of high-risk patients infected with SARS-CoV-2 treated withtin the framework of a cohort ATU ('Autorisation temporaire d'utilisation') delivered by the French drug agency (ANSM).

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Hôpital Universitaire Necker Enfants Malades


title: Observational Study of Patients Treated With Hot AXIOS® Prosthesis in Real Life Conditions -

acronym: REALAXIOS

summary:
Regulatory Context The CNEDiMTS makes the renewal of registration conditional on the transmission of the results of a well-conducted prospective study, carried out with Hot AXIOS, the objective of which is to evaluate the interest of this device in real conditions of use with regard to effectiveness and complications after a minimum follow-up of 3 months.

Operators are trained in the use of the equipment (practice on ex-vivo model and/or prior stent placement) and undertake to comply with the rules and formalities of use.

Primary efficacy objective :

To evaluate the efficacy of endoscopic trans digestive drainage after use of the Hot AXIOS prosthesis in the treatment of pancreatic collections (incompletely fluid or necrotic) at 3 months.

Secondary Objectives :

Assessment of the following elements :

Morbidity (complication rates) and mortality per- and post-procedure
Recurrence rate of pancreatic collection
Evolution of the quality of life questionnaire (SQ5D5L)
Technical success rate of prosthesis placement and removal success rate of the prosthesis
Search for factors predictive of clinical success of endoscopic pancreatic drainage with the Hot Axios prosthesis.

Study design Non-interventional/observational (RIPH 3 type), multi-center, prospective study with consecutive inclusions evaluating the Hot AXIOS® prosthetic device.

Non-inclusion registry A minimum amount of information will be collected anonymously, including sex, age, indication of drainage and reason for non-inclusion (e.g. refusal of the patient, of the investigator for impossibility of following the patient in the centre or other reasons to be specified). Generic information will be affixed in each centre participating in the study indicating: "In application of the provisions of the Data Protection Act, general information on the possibility that personal data may be used for research purposes must be provided in any establishment or centre where prevention, diagnosis and care activities are carried out". This must be exhaustive and rigorously maintained.

Equipment used in endoscopy Hot AXIOS™ - self-expanding metal prosthesis with a lumen diameter of 6 to 20 mm and collar length of 8 and 10 mm or any future similar device marketed under the same name at the time of the study.

Technique Insertion of the material under echo-endoscopic control -- possible but not systematic dilatation -- guide wire with hydrophilic tip - Puncture and release under echo-endoscopic control according to the centre's usual practice.

Registration The data will be collected anonymously in an electronic computer database using eCRFs.

Statistical analysis The evaluation of the clinical success of endoscopic pancreatic necrosectomy with metallic prosthesis will first consist in describing its efficacy according to the criteria described above.

Analysis plan :

The statistical analysis will first include a description of the study population with the number of patients falling under the indication and treated with the Hot AXIOS system at the recruiting centers (source population), the number of eligible patients who consented to participate in the study, the number of patients included (study population), the number of subjects who made each visit and were analyzed, premature exits (deaths, lost to follow-up) will be reported and described in the form of a flow chart.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Clinique Jean Mermoz
brest Hospital
St Joseph Hospital
Nancy Hospital
Limoges hospital
Nice Hospital
APHP saint antoine
European Hospital
Saint Etienne Hospital
Avignon Hospital
Clermont-ferrand hospital
Hôpital privé des peupliers
Lille Hospital
Centre Hospitalier Jacques Lacarin
APHM
Poitiers Hospital
Polyclinique Saint Côme


title: Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

acronym: CHANGE

summary:
Multiparametric MRI of the prostate is recommended before each prostate biopsy. It identifies suspicious areas which will then be the subject of targeted biopsies. However, MRI suffers from low specificity and moderate inter-reader reproducibility, including with the use of the PI-RADS version 2.1 score.

We are developing, within the framework of RHU PERFUSE, a computer-aided diagnosis system (CAD) for the detection of ISUP ≥2 cancers. This system has been trained on a database of patients who had prostate MRI and prostatectomy at the Hospices Civils de Lyon and performed well on a database of patients who had prostate MRI before biopsy at the Hopices civils de Lyon.

However, one of the weaknesses of artificial intelligence systems is their low robustness when tested on MRI images from different manufacturers or institutions.

The goal of the CHANGE study is to build a prospective multicenter cohort of patients who underwent prostate multiparametric MRI followed by systematic and targeted prostate biopsies. The cohort will be used for the final external validation of the CAD developed in PERFUSE.

primary_purpose: Diagnostic

ipd_sharing: Yes

ipd_sharing_description: After publication of the results of the trial, the CHANGE cohort will be made partially accessible to other investigators wishing to test a CAD system aimed at detecting/localizing prostate cancer on MR images while respecting patient information. Request for access to pseudonymized data will be reviewed by the Trial Steering Committee that will grant access or not. To gain access, requestors will be required to sign a data access agreement. Of note, investigators will have access only to the MR images and not to the histological findings. After analysis of the CHANGE MR images by their CAD system, the investigator will be requested to send the results to the Hospices Civils de Lyon. The comparison between the CAD findings and the targeted and systematic biopsy findings will be made by the Hospices Civils de Lyon that will then inform the investigator of the CAD diagnostic performance.

location_facility: Department of Urology, Clinique Beausoleil Montpellier

location_facility: Department of radiology and urology, CHU Pellegrin

location_facility: Department of radiology and urology, CHU de Lille

location_facility: Department of Radiology and Urology, Institut Paoli-Calmettes Marseille

location_facility: Department of Urology, Quint Fonsegrives

location_facility: Department of Radiology and Urology, Hopital Européen Marseille

location_facility: Department Urology, Clinique urologique Nantes Atlantis

location_facility: Department of radiology and urology, Hôpital la Pitié Salpêtrière

location_facility: Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse

location_facility: Department of urology, CHU de Saint-Étienne Hôpital Nord

location_facility: Department of radiology and urology, Hôpital Saint Joseph Saint Luc

location_facility: Department of urology and Radiology, CHU Grenoble Alpes

location_facility: Department of urology and radiology, CHLS

location_facility: Department of radiology and urology, Hôpital Edouard Herriot

location_facility: Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg


title: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma

acronym: RADIO-RYTHMIC

summary: The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

lead_sponsor: Institut Curie

location_facility: Institut de Cancérologie de Lorraine Nancy

location_facility: Institut de Cancérologie de l'Ouest Angers


title: Observational Register of Patients With haEmophilia A tReated With Afstyla®

acronym: OPERA

summary: Record real life data of patients with Hemophilia A and treated with Afstyla® to assess the effectiveness and the safety of the treatment used as prophylaxis, prevention of bleeding (e.g. surgery) or on-demand treatment during 3 years after patient inclusion

lead_sponsor: CSL Behring

location_facility:
CHRU Lille
Hôpital Necker
Hôpital Simone Veil
CHU Limoges
CHU Caen
CHU Clermont-Ferrand
Hôpital Mignot
CHU Montpellier
CHRU de Tours
CHU Saint-Etienne
CHU Nantes
CHU Rennes
CRC-MHC Hôpital Kremlin Bicêtre
CHU Rouen
CHU Brest
Hôpital Hautepierre
CHU Chambéry

intervention_type: Biological


title: Hizentra® in Inflammatory Neuropathies - pHeNIx Study

acronym: pHeNIx

summary: The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes).

status: Suspended

location_facility:
CHU Angers
Hôpital Raymond poincaré, Garches
Hôpital Henri Mondor
CHRU Brest
CHU Toulouse
Hôpital Dupuytren
Hôpital Pasteur
Hôpital de la Timone
Hôpital Pierre Wertheimer,HCL
Hôpital Charles Nicolle
CHU Montpellier
CHU Nantes
Hôpital Roger Salengro, CHU Lille
Hôpital Pellegrin
Hôpital Bicêtre
La Pitié-Salpêtrière
Hôpital Lariboisière


title: Rifabutin Versus Rifampicin for Treatment of Staphylococcal Prosthetic Joint Infection Treated With Debridement, Antibiotics and Implant Retention (DAIR Strategy): a Multicenter Randomized, Open-label, Non-inferiority Trial

acronym: RIFAMAB

summary: Rifampicin, is key in the treatment of staphylococcal PJIs. Rifabutin has a better profile of tolerance than rifampicin regarding the risk of interaction with concomitant medications and liver disorders. The hypothesis is that rifabutin may be an alternative antibiotic option as efficient as rifampicin for the treatment of staphylococcal PJIs, with a better safety profile. The investigator aim to demonstrate the non-inferiority of rifabutin as compared with rifampicin prescribed in combination treatment for PJIs.

lead_sponsor: Tourcoing Hospital

location_facility:
CHU Dijon Bourgogne
CHRU Lille
CHRU Brest
Hospices Civils de Lyon
CH Annecy Genevois
CH Cornouaille
CHU Amiens Picardie
Clinique de la Sauvegarde
CHRU Strasbourg
CHU Bordeaux
CHU Besançon
CHU Nice
CH Tourcoing
CHU de Rennes
CHRU Tours
APHP Hôpital Ambroise Paré


title: Observational Registry of Patients With Von WilLEbrand Disease Treated With Voncento®

acronym: OPALE

summary: Description of the long-term evolution of patients with von Willebrand disease and treated with Voncento® and of the hemostatic efficacy in the prevention and the treatment of non-surgical bleeding episodes and prevention of surgical bleeding during 2 years after patient inclusion.

location_facility:
CHU Lariboisière
CHU Strasbourg
Hôpital Necker
Hôpital Simone Veil
Hôpital Saint-Eloi
CHRU Nancy
CHU Caen
CHU Morvan Brest
CHU Lyon
Hôpital Mignot
CHU Bordeaux
Hôpital Cochin
CHU Besançon
CHU Nantes
CHU Rouen
CHU Rennes
Hôpital Bicêtre


title: Evaluation of the Relationship Between Anti-PD-1 Exposure and Tumour VOLUME in Patients Treated for Classical HODgkin's Lymphoma.

acronym: REVOLUMHOD

summary:
Anti-PD-1antibodies (iPD-1) are indicated as monotherapy in the treatment of adult patients with classical LH. The recommended dosage in LH is based on solid tumour experience and no dose-concentration-effect studies have been conducted.

According to the literature, therapeutic efficacy appears to be highly variable, and could be related to differences in treatment exposure.

Since Total metabolic tumor volume (TMTV) is a prognostic factor in LH and the clearance of iPD-1, and thus exposure to iPD-1, is related to clinical efficacy, we hypothesize that TMTV influences the exposure to iPD-1 and thus its therapeutic efficacy.

The aim of this study is to evaluate the relationship between TMTV and anti-PD-1 exposure in refractory or relapsed LH.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Angers
GHBS Lorient
CHU Rennes
CH St Malo
CHU Poitiers
AP-HP Henri Mondor
CH St Brieuc
Hôpital privé Sévigné
CHBA Vannes
CHU Bordeaux
CHU Montpellier
CHU Tours
CHU Dijon
CHU Nantes
CH Orléans
CHU Brest


title: Double-blind, Randomized, Multi-center, Non-inferiority Clinical Trial Comparing Two Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children

summary:
Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia.

Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. Available pediatric studies highlighted positive/promising results of PBM with excellent safety and no adverse effects. Nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines.

Considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two PBM protocols with same PBM parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced OM of WHO grade 2 or higher.

lead_sponsor: University Hospital, Toulouse

location_facility:
University hospital of Angers
University hospital of Besançon
University hospital of Strasbourg
Hôpital La Timone
Armand Trousseau Hospital
University hospital of Limoges
University hospital of Lille
University hospital of Poitiers
University hospital of Saint-Etienne
University hospital of Nancy
University hospital of Reims
University hospital of Grenoble
University hospital of Toulouse
University Hospital of Nice
University Hospital of Tours
University hospital of Rouen


title: Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?

acronym: FERTICOVID

summary: During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.

location_facility: Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye

location_facility: CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS

location_facility: Hospices Civils de Lyon - Service AMP-CECOS

location_facility: CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims

location_facility: Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS

location_facility: AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS

location_facility: CHU de Clermont-Ferrand - Laboratoire de Virologie

location_facility: CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS

location_facility: CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS

location_facility: CHU de Strasbourg - Service de Biologie de la reproduction

location_facility: CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS

location_facility: AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction

location_facility: AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction

location_facility: AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS

intervention_type: Diagnostic Test


type: EudraCT Number

title: Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial.

acronym: CHASAP

summary: A randomized clinical trial to assess the efficiency of acetylsalicylic acid (aspirin) 150 mg/day started before 15 weeks of gestation in the prevention on maternal and fœtal complications in pregnant women with chronic hypertension.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Prospective Descriptive Study on the Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid19

summary:
Clinical thoracic ultrasound plays an important role in the exploration, diagnosis and follow-up of thoracic pathologies.

The COVID (Coronavirus Disease) epidemic is leading to a large influx of patients in the emergency department with respiratory disorders. The rapid diagnosis of respiratory disorders in infected patients is important for further management.

Chest ultrasound has already demonstrated its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray.

However, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.


title: Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study

acronym: RESEDAE

summary: This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes

location_facility: Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes


title: CPX-351 in Higher Risk Myelodysplastic Syndromes: a Phase I/ II Study as First Line or After Hypomethylating-agents Failure

summary: Study of the efficacy of CPX-351 treatment in patients with higher risk myelodysplastic syndromes : as first line treatment or after hypomethylating agents failure

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: IUCT-oncopole - Fédération Hématologie - Médecine Interne

location_facility: CHU d'Angers - Service des maladies du sang

location_facility: CHU de Besançon - Hôpital Jean Minjoz - Service d'hématologie clinique

location_facility: CHU-Hôpital Archet I - Service d'Hématologie Clinique

location_facility: CHU de Bordeaux - Hôpital de Haut-Lévêque - Service des maladies du sang

location_facility: CHU d'Amiens - Service d'hématologie clinique et thérapie cellulaire

location_facility: CHU de Grenoble - Clinique universitaire d'hématologie

location_facility: Hôpital Pontchaillou - Service d'hématologie clinique

location_facility: Institut de Cancérologie Lucien Neuwirth - Hématologie Clinique - Thérapie Cellulaire

location_facility: Hôpital Saint Louis - Service Hématologie Séniors

location_facility: CHU de Poitiers - Service d'onco-hématologie et thérapie cellulaire

location_facility: CHRU de Limoges - Hôpital Dupuytren - Service d'hématologie clinique et thérapie cellulaire

location_facility: CHU Hôtel Dieu - Service d'Hématologie Clinique

location_facility: Institut Paoli Calmettes - Unité d'hématologie 3

location_facility: Centre hospitalier Victor Dupouy - Service d'Hématologie


type: Other Grant/Funding Number

title: Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial

acronym: eo-Drive

summary:
The primary objective of this study is to compare treatment failure rates between a group of eosinophilic (eosinophilia > 2% on day 1 of hospitalization) patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo.

Secondarily, treatment failure rates will also be compared between a group of non-eosinophilic patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo. Study arms will also be compared for additional aspects of efficacy and safety:

speed of recovery during the initial hospitalization;
corticosteroid side effects / induced comorbidities;
changes in symptoms and episodes of exacerbation;
pulmonary function, oxygen use and ventilation;
patient trajectories and resource use (e.g. survival, consults, episodes of hospitalization, medications);
drug consumption (especially as relates to COPD management, exacerbations and induced comorbidities);
health status, quality of life, activity/disability;
patient safety / adverse events in general.

Eosinophilia thresholds optimizing the prediction of corticosteroid response and COPD outcomes will be re-evaluated. The relationships between corticosteroid response and key biomarkers (e.g. infectious groups) will be thoroughly explored, including within eosinophil strata. Potential gender subgroups differences will also be evaluated.

Finally, in prevision of further exploratory studies, a biological collection and an imaging library will be created in association with this protocol. The biological collection will be used to explore the genetic basis and physiology linked with treatment response, gender and patient trajectories. The image library will be used as a platform for the exploration of new imaging markers developed, for example, via machine learning and affiliated techniques.

ReferenceCitation: Suehs CM, Zysman M, Chenivesse C, Burgel PR, Couturaud F, Deslee G, Berger P, Raherison C, Devouassoux G, Brousse C, Roche N, Molimard M, Chinet T, Devillier P, Chanez P, Kessler R, Didier A, Martinat Y, Le Rouzic O, Bourdin A. Prioritising outcomes for evaluating eosinophil-guided corticosteroid therapy among patients with acute COPD exacerbations requiring hospitalisation: a Delphi consensus study. BMJ Open. 2020 Jul 1;10(7):e035811. doi: 10.1136/bmjopen-2019-035811.

ipd_sharing_description:
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available to persons who address a reasonable dataset request to the sponsor coordinating team (c/o Dr Carey Suehs, Department of Medical Information, Hôpital La Colombière, 39 avenue Charles Flahault, 34295 Montpellier Cedex 5, France).

In accordance with French law, dataset usage requests must by approved by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel) prior to access.

lead_sponsor: University Hospital, Montpellier

location_facility: Centre hospitalier intercommunal de Créteil

location_facility: APHP - Hôpital Universitaire Pitié-Salpétrière


title: Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia

acronym: MVO

summary:
Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children.

The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital of Dijon
University Hospital of Tours
University Hospital of Bordeaux
University Hospital of Rennes
Centre Oscar Lambret
Hôpital La Timone
Hôpital Trousseau
Institut Curie
University Hospital of Poitiers
University Hospital of Nice
Univesity Hostipal of Amiens
Gustave Roussy
University Hospital of Nantes
University of Brest
University Hospital of La Réunion
University Hospital of Limoges


title: Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)

acronym: SINNO-RA

summary:
Rheumatoid arthritis (RA) is one of the main chronic inflammatory rheumatic diseases (RCI), with a prevalence of about 0.4% of the population.

First-line treatment with immunomodulators (synthetic and biological Disease Modifying Anti-Rheumatic Drugs (sDMARDs) including methotrexate) is not sufficiently effective in 40% of cases. These patients are then treated with biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) called biotherapies. As the use of these bio-drugs increases each year, they become a major public health and economic issue. Their growth is only just beginning, as they are among the major providers of pharmaceutical innovation.

There are about ten bio-drugs currently on the market for rheumatoid arthritis with an average annual treatment cost of 8 to 12 000 euros per patient. This cost is 20 times higher than that of sDMARDs. However, among patients treated with biotherapy, clinical practice shows that approximately one-third (33%) will not respond to the selected bio-drugs.

In the event of non-response, physicians currently have no choice but to rotate empirically between different treatments, as no tools capable of predicting response or non-response to these molecules are currently available. SinnoTest® software, a predictive algorithm for responding to bDMARDs by analyzing proteomic biomarkers, will clarify this choice of prescription for patients with failed RA of a first bDMARD in the anti-TNF family.

status: Withdrawn

primary_purpose: Supportive Care

ReferenceCitation: Nguyen MVC, Baillet A, Romand X, Trocmé C, Courtier A, Marotte H, Thomas T, Soubrier M, Miossec P, Tébib J, Grange L, Toussaint B, Lequerré T, Vittecoq O, Gaudin P. Prealbumin, platelet factor 4 and S100A12 combination at baseline predicts good response to TNF alpha inhibitors in rheumatoid arthritis. Joint Bone Spine. 2019 Mar;86(2):195-201. doi: 10.1016/j.jbspin.2018.05.006. Epub 2018 Jun 6.

ReferenceCitation: Nguyen MVC, Adrait A, Baillet A, Trocmé C, Gottenberg JE, Gaudin P. Identification of cartilage oligomeric matrix protein as biomarker predicting abatacept response in rheumatoid arthritis patients with insufficient response to a first anti-TNFα treatment. Joint Bone Spine. 2019 May;86(3):401-403. doi: 10.1016/j.jbspin.2018.09.005. Epub 2018 Sep 19.

ReferenceCitation: Baillet A, Trocmé C, Romand X, Nguyen CMV, Courtier A, Toussaint B, Gaudin P, Epaulard O. Calprotectin discriminates septic arthritis from pseudogout and rheumatoid arthritis. Rheumatology (Oxford). 2019 Sep 1;58(9):1644-1648. doi: 10.1093/rheumatology/kez098.

ReferenceCitation: Baillet A, Trocmé C, Berthier S, Arlotto M, Grange L, Chenau J, Quétant S, Sève M, Berger F, Juvin R, Morel F, Gaudin P. Synovial fluid proteomic fingerprint: S100A8, S100A9 and S100A12 proteins discriminate rheumatoid arthritis from other inflammatory joint diseases. Rheumatology (Oxford). 2010 Apr;49(4):671-82. doi: 10.1093/rheumatology/kep452. Epub 2010 Jan 25.

ReferenceCitation: Trocmé C, Marotte H, Baillet A, Pallot-Prades B, Garin J, Grange L, Miossec P, Tebib J, Berger F, Nissen MJ, Juvin R, Morel F, Gaudin P. Apolipoprotein A-I and platelet factor 4 are biomarkers for infliximab response in rheumatoid arthritis. Ann Rheum Dis. 2009 Aug;68(8):1328-33. doi: 10.1136/ard.2008.093153. Epub 2008 Jul 29.

lead_sponsor: University Hospital, Grenoble

location_facility: APHP Groupe hospitalier Pitié-Salpêtrière

location_facility: Groupe Hospitalier Pellegrin - CHU de Bordeaux


title: SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR: OPTIMIZATION OF THE PROCEDURE BY REPOSITIONING THE ELECTRODES AND RESEARCH OF THE PREDICTIVE FACTORS OF FAILURE

acronym: SIS

summary: S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined. Moreover, slight variations in electrode positioning may change vector configuration and therefore improve screening success rates

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier de PAU

location_facility:
CHU de Caen
Hopital Saint Philivert
Hopitl Cardiologique Louis Pradel
APHP - Pitié Salpêtrière
CHU deToulouse
CHU de Nantes
CHRU de Lille
CHU de Limoges
CHU de Nancy
AP-HP Hôpital européen Georges-Pompidou
CH de Pau
CHU de Tours
CHRU de Strasbourg
Clinique Pasteur
CHRU de BREST
CHU de Rennes


title: A Randomized, Placebo-controlled, Double-blinded, Multicentre Study Evaluating the Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas

acronym: REGOSTA

summary:
This is a randomized, double-blinded, 2 arms study concerning patients with bone sarcoma after the first line therapy.

In the first arm, patients will be treated with regorafenib for a maximum of 12 months as maintenance therapy after first line therapy (chemotherapy and surgery), whereas in the second arm, patients will be treated with placebo (standard of care).

The comparison between this two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement.

lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier Régional de Strasbourg Hautepierre

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut de Cancérologie Strasbourg Europe


ReferenceCitation: Leducq S, Caille A, Barbarot S, Bénéton N, Bessis D, Boccara O, Bursztejn AC, Chiaverini C, Dompmartin A, Droitcourt C, Gissot V, Goga D, Guibaud L, Herbreteau D, Le Touze A, Léauté-Labrèze C, Lorette G, Mallet S, Martin L, Mazereeuw-Hautier J, Phan A, Plantin P, Quéré I, Vabres P, Bourgoin H, Giraudeau B, Maruani A; Groupe de Recherche de la Société Française de Dermatologie Pédiatrique. Topical sirolimus 0.1% for treating cutaneous microcystic lymphatic malformations in children and adults (TOPICAL): protocol for a multicenter phase 2, within-person, randomized, double-blind, vehicle-controlled clinical trial. Trials. 2019 Dec 17;20(1):739. doi: 10.1186/s13063-019-3767-8.

family: Leducq

full_name: Sophie Leducq

given: Sophie

family: Caille

full_name: Agnès Caille

given: Agnès

family: Barbarot

full_name: Sébastien Barbarot

given: Sébastien

family: Bénéton

full_name: Nathalie Bénéton

given: Nathalie

family: Bessis

full_name: Didier Bessis

family: Boccara

full_name: Olivia Boccara

given: Olivia

family: Bursztejn

full_name: Anne-Claire Bursztejn

given: Anne-Claire

family: Chiaverini

full_name: Christine Chiaverini

given: Christine

family: Dompmartin

full_name: Anne Dompmartin

given: Anne

family: Droitcourt

full_name: Catherine Droitcourt

given: Catherine

family: Gissot

full_name: Valérie Gissot

given: Valérie

family: Goga

full_name: Dominique Goga

given: Dominique

family: Guibaud

full_name: Laurent Guibaud

given: Laurent

family: Herbreteau

full_name: Denis Herbreteau

given: Denis

family: Le Touze

full_name: Anne Le Touze

family: Léauté-Labrèze

full_name: Christine Léauté-Labrèze

family: Lorette

full_name: Gérard Lorette

given: Gérard

family: Mallet

full_name: Stéphanie Mallet

given: Stéphanie

family: Martin

full_name: Ludovic Martin

given: Ludovic

family: Mazereeuw-Hautier

full_name: Juliette Mazereeuw-Hautier

given: Juliette

family: Phan

full_name: Alice Phan

given: Alice

family: Plantin

full_name: Patrice Plantin

given: Patrice

family: Quéré

full_name: Isabelle Quéré

given: Isabelle

family: Vabres

full_name: Pierre Vabres

given: Pierre

family: Bourgoin

full_name: Hélène Bourgoin

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

location_facility:
LYON AD
BORDEAUX
ANGERS
NECKER
QUIMPER
TOURS
NANTES
RENNES
TOULOUSE
Lariboisiere
Marseille
NICE
DIJON
CAEN
LYON PED
NANCY
Montpellier

title: 0.1% Topical Sirolimus in the Treatment of Cutaneous Microcystic Lymphatic Malformations in Children and Adults: Phase II, Split-body Randomized, Double-blind, Vehicle-controlled Clinical Trial

summary: Cutaneous microcystic lymphatic malformations (CMLMs) are rare conditions of children and adults resulting from abnormal embryologic development of lymphatic vessels. They present as clusters of vesicles full of lymph and blood of various extent. They ooze and bleed, inducing maceration, esthetic impairment, scars, pain, bacterial infections and impaired quality of life. Currently, treatments for CMLMs are disappointing, and their management is challenging. Sirolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine/threonine protein kinase involved in cell growth and proliferation, cellular metabolism, autophagy and angio-lymphangiogenesis. Topical sirolimus, known to be efficient and well tolerated in cutaneous angiofibromas linked to tuberous sclerosis, has recently been reported effective in few reports of patients with CMLMs. The objective of this trial is to compare the efficacy and safety of a 12-week application of 0.1% topical sirolimus versus topical vehicle in CMLMs in children and adults.


title: Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.

acronym: OptiTHO

summary:
In blunt chest trauma patients without immediate life-threatening conditions, delayed respiratory failure and need for mechanical ventilation may still occur in 12 to 40% of patients, depending on the severity of the trauma, the preexisting conditions and the intensity of initial management.

In this context, non-invasive ventilation (NIV) is recommended in hypoxemic chest trauma patients, defined as a PaO2/FiO2 ratio < 200 mmHg. However, there is a large heterogeneity among studies regarding the severity of injuries, the degree of hypoxemia and the timing of enrollment. The interest of a preventive strategy during the early phase of blunt chest trauma, before the occurrence of respiratory distress or severe hypoxemia, is not formally established in the literature. Moreover, high-flow nasal oxygen therapy (HFNC-O2) appears to be a reliable and better tolerated alternative to conventional oxygen therapy (COT), associated with a significant reduction in intubation rate in hypoxemic patients.

Two NIV strategies are compared:

In the experimental strategy, NIV is performed after inclusion in patients with moderate hypoxemia, defined by a PaO2/FiO2 ratio < 300 mmHg. The minimally required duration of NIV was 4 hours per day for at least 2 calendar days.
In the control group, patients receive oxygen from nasal cannula or high concentration oxygen mask according to the FiO2 needed to achieve SpO2 > 92%. NIV is initiated only in patients having PaO2/FiO2 ratio < 200 mmHg under COT.

Investigators hypothesized that an early strategy associating HFNC-O2 and preventive NIV in hypoxemic blunt chest trauma patients may reduce the need for mechanical ventilation compared to the recommended strategy associating COT and late NIV.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Strasbourg -Hôpital de Hautepierre

intervention_type: Combination Product


lead_sponsor: Hospices Civils de Lyon

acronym: PROGRESSION

location_facility: APHP - Hôpital Xavier Bichat-Claude Bernard

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis Pradel

location_facility: CHU de Caen - Hôpital de la Côte de Nacre

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

source: euctr

title: Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized Trial

summary:
Idiopathic pulmonary fibrosis (IPF) is a prototype of chronic, progressive, and fibrotic lung disease. It has been considered rare, with an incidence estimated to 11.5 cases per 100 000 individuals per year. Increasing rates of hospital admissions and deaths due to IPF suggest an increasing burden of disease. The median survival time from diagnosis is 2-4 years.

Recently two disease-modifying therapies, pirfenidone and nintedanib, have been approved worldwide. Both drugs reduce the disease progression as measured by progressive decline in forced vital capacity (FVC), with a reduction of overall mortality showed by meta-analysis of phase III pirfenidone trials.

However, progression of disease continues to occur despite the currently available drug therapy. Many patients die from progressive, chronic hypoxemic respiratory failure, or less frequently from acute exacerbation of pulmonary fibrosis. In these patients, no data are available to guide management between continuation of the prescribed antifibrotic drug, to switch to the other available antifibrotic drug, or to combine the available drugs.

The combination of nintedanib and pirfenidone is not recommended outside clinical trials. However, although both antifibrotic drugs were developed and approved as monotherapy, two recent trials have suggested the feasibility and safety of combining them over a 12-24 weeks period. These results encourage further studies of combination treatment with pirfenidone and nintedanib in patients with IPF. Such study is timely, as there is a risk that clinicians facing the continued worsening of disease in patients receiving one of the available drugs may prescribe both drugs combined outside clinical trials, potentially exposing patients to a currently unknown risk.

This study will evaluate the efficacy and tolerance of the combination pirfenidone and nintedanib as compared to a "switch monotherapy": i.e. switching from the current to the other of the two existing drugs prescribed as monotherapy, in patients who present chronic worsening IPF despite receiving either pirfenidone or nintedanib and as to a "control group": i.e.treatment still be on as before randomization (pirfenidone or nintedanib).


title: Comparison of Trough Level-based Spacing and Clinical-based Spacing of Infliximab Infusions in Patients With Inflammatory Bowel Disease in Deep Remission; A Prospective, Multicenter, Open-label, Randomized, Controlled Study

acronym: SPACIFIX

summary: Comparison of trough level-based spacing and clinical-based spacing of infliximab infusions in patients with inflammatory bowel disease in deep remission A prospective, multicenter, open-label, randomized, controlled Study

location_facility:
APHP Beaujon Hospital
Clermont-Ferrand University Hospital
Rennes University Hospital
Besançon University Hospital
Lille University Hospital
Nîmes University Hospital
Pineton de Chambrun
Nice University Hospital
Amiens University Hospital
CHRU Nancy - Hôpitaux de Brabois
APHP Paris Cochin
Caen University Hospital
Nantes University Hospital
Bordeaux University Hospital
Toulouse University Hospital
Saint Etienne University Hospital


title: Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy

acronym: TEMPOS

summary:
The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, randomized-controlled medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment.

Eight patients/year/center are expected to be recruited in 2 years in about twenty participating centers.

In total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities.

lead_sponsor: Center Eugene Marquis

location_facility: Institut de Cancérologie de l'Ouest - Site Gauducheau

location_facility: Institut régional du Cancer de Montpellier


title: A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

summary: To evaluate the clinical benefit of a post-operative adjuvant therapy combining radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine in Triple Negative Breast Cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy.

location_facility:
Centre Antoine Lacassagne
Centre Léon Bérard
Institut de Cancérologie de l'Ouest
CHRU Besançon
Institut Jean Godinot
Clinique de la Sauvegarde
Centre Paul Strauss
Centre d'Oncologie Radiothérapie 37
Hopital Prive Jean Mermoz
Institut Paoli Calmettes
Institut Curie
Institut Sainte Catherine
Hôpital Drôme Ardèche
Centre Francois Baclesse
GH Pitié-Salpêtrière-Charles Foix


title: Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients

acronym: ONCOPRO

summary:
Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal.

In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma…) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development.

Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation.

Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.

location_facility: Service d'Oto-Rhino-Laryngologie de l'Hôpital de la Croix-Rousse

location_facility: Service de Pneumologie de l'Hôpital Lyon Sud

location_facility: Service de Dermatologie de l'hôpital Lyon Sud

location_facility: Service de NEURO-ONCOLOGIE du Groupement Hospitalier EST

location_facility: Service de Pneumologie de l'hôpital de la Croix-Rousse

location_facility: Service de Chirurgie de l'hôpital Lyon Sud

location_facility: Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE du Centre Hospitalier Lyon Sud

location_facility: Service de Pneumologie du Groupement Hospitalier Est

location_facility: Service de Gynécologie de l'hôpital Lyon Sud

location_facility: Service de Gynécologie du Groupement Hospitalier Est

location_facility: Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'hôpital de la Croix-Rousse

location_facility: Service d'Hématologie de l'Hôpital Lyon Sud

location_facility: Service d'Oncologie médicale du Centre hospitalier Lyon Sud

location_facility: Service d'Urologie de l'Hôpital E. Herriot

location_facility: Service de Gynécologie de l'hôpital de la Croix-Rousse

location_facility: Service d'Urologie de l'hôpital Lyon Sud

location_facility: Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'Hôpital E. Herriot