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Recruiting

Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over (ADAGE)

ClinicalTrials.gov ID NCT02355379
Sponsor Federation Francophone de Cancerologie Digestive
Information provided by Federation Francophone de Cancerologie Digestive (Responsible Party)
Last Update Posted 2024-07-08
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Study Overview

Brief Summary

Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly patients in this study were highly selected and patients older than 80 represented only 0.7% of the total population. Thus, there is still a concern about the benefit of adjuvant 5FU-based chemotherapy in very elderly unselected patients.

The recommended treatment for stage III adjuvant chemotherapy is a combination of fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival advantage in elderly patients.

Altogether there are still two matters of debate:

  • First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit elderly patients?
  • Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly patients? The aim of this randomized phase III study is to evaluate the benefit for disease-free survival of adjuvant chemotherapy in elderly patient and which chemotherapy.

The elderly patient population will be dichotomized into two groups according to physician's choice after a multidisciplinary evaluation involving a geriatrician, with two different randomization assignments. The patients with an expected life-expectancy below 4 years according Lee score are excluded of this study.

Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch repair deficiency), therefore an evaluation of specific biological prognostic factors is needed in elderly population.

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Detailed Description

Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly patients in this study were highly selected and patients older than 80 represented only 0.7% of the total population. Thus, there is still a concern about the benefit of adjuvant 5FU-based chemotherapy in very elderly unselected patients.

The recommended treatment for stage III adjuvant chemotherapy is a combination of fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival advantage in elderly patients.

Altogether there are still two matters of debate:

  • First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit elderly patients?
  • Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly patients? The aim of this randomized phase III study is to evaluate the benefit for disease-free survival of adjuvant chemotherapy in elderly patient and which chemotherapy.

The elderly patient population will be dichotomized into two groups according to physician's choice after a multidisciplinary evaluation involving a geriatrician, with two different randomization assignments. The patients with an expected life-expectancy below 4 years according Lee score are excluded of this study.

Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch repair deficiency), therefore an evaluation of specific biological prognostic factors is needed in elderly population.

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Official Title
Randomised Phase III Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over Intergroup Trial: Ffcd, Gercor, Gerico, Unicancer-gi
Conditions
Colonic Adenocarcinoma
Intervention / Treatment
  • Drug: LV5FU2 or capectitabine
  • Drug: FOLFOX4 or XELOX
  • Other: Observation
  • Drug: LV5FU2 or capecitabine
  • Drug: LV5FU2 or capectitabine
  • Drug: FOLFOX4 or XELOX
  • Other: Observation
  • Drug: LV5FU2 or capecitabine
Other Study ID Numbers
  • PRODIGE34-ADAGE
Study Start
2015-01
Primary Completion (Estimated)
2024-12
Study Completion (Estimated)
2025-08
Enrollment (Estimated)
774
Study Type
Interventional
Phase
Phase 3

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Study Contact

Name: Martina Schneider

Phone Number: +33 3 80 39 34 83

Email: martina.schneider@u-bourgogne.fr

Study Contact Backup

Name: Jaique Cario

Phone Number: +33 3 80 39 34 86

Email: jaique.cario_isat@u-bourgogne.fr

This study has 140 locations
France
Abbeville CEDEX, France, 80142

Recruiting

CH d'Abbeville
Contact:
Mathieu PAUWELS, Dr
pauwels.mathieu@ch-abbeville.fr; pauwels.gastro@wanadoo.fr
Agen, France

Recruiting

CROMG
Contact:
Adela CAUCHOIS
05 53 69 12 00
Principal Investigator:
Adela CAUCHOIS
Sub-Investigator:
Sévrine GUARNIERI
Sub-Investigator:
Xavier CARLES
Sub-Investigator:
Olivier BERNARD
Aix-en-Provence, France, 13616

Recruiting

Centre hospitalier du Pays d'Aix
Contact:
Sophie NAHON BRISSONNEAU, Dr
arc.emrc13@gmail.com
Albi, France, 81000

Recruiting

Centre hospitalier d'Albi
Contact:
Nadia MUNSCH, Dr
nadia.munsch@ch-albi.rss.fr
Albi, France, 81030

Recruiting

Clinique Claude Bernard
Contact:
Yann BERGE, Dr
berge@claude-bernard-albi.com
Albi, France

Recruiting

Clinique Claude Bernard
Contact:
Yann BERGE
berge@claude-bernard-albi.com
Principal Investigator:
Yann BERGE
Sub-Investigator:
Philippe HOUYAU
Sub-Investigator:
Marie-Hélène GASPARD
Sub-Investigator:
Amaury SYLVESTRE
Alès, France, 30103

Recruiting

Centre Oncogard
Contact:
Jacques CRETIN, Dr
cretinjacques@yahoo.fr
Amiens CEDEX 1, France, 80054

Recruiting

Hôpital Sud
Contact:
Vincent HAUTEFEUILLE, Dr
hautefeuille.vincent@chu-amiens.fr
Angers CEDEX 2, France, 49055

Recruiting

ICO Site Paul Papin
Contact:
Sandrine HIRET, Dr
Sandrine.hiret@ico.unicancer.fr
Angers CEDEX 9, France, 49933

Recruiting

CHU d'Angers
Contact:
Nathalie BAIZE, Dr
nabaize@chu-angers.fr
Annemasse, France

Recruiting

HOP Privé
Contact:
Oxana SHESTAEVA
o.shestaeva@ramsaygds.fr
Principal Investigator:
Oxana SHESTAEVA
Argenteuil, France, 95107

Recruiting

CH Victor Dupouy
Contact:
Arnaud BOUTAN-LAROZE, Dr
arnaud.boutan-laroze@ch-argenteuil.fr
Arras CEDEX, France, 62012

Recruiting

Hôpital Les Bonnettes
Contact:
Bruno HUGUENIN, Dr
drbhuguenin@orange.fr
Arras, France

Recruiting

Hôpital Privé Bonnettes
Contact:
Bruno HUGUENIN
drbhuguenin@orange.fr
Principal Investigator:
Bruno HUGUENIN
Sub-Investigator:
Sophie BLANC
Aubenas CEDEX, France, 07205

Recruiting

Centre Hospitalier Ardèche Méridionale
Contact:
Brigitte VELAY, Dr
brigitte.velay@ch-ardeche-meridionale.fr
Auxerre, France, 89000

Recruiting

CH D'Auxerre
Contact:
Anne-Laure VILLING, Dr
alvilling@ch-auxerre.fr
Avignon CEDEX, France, 84918

Recruiting

Institut Sainte Catherine
Contact:
Laurent MINEUR, Dr
l.mineur@isc84.org
Avignon, France, 84902

Recruiting

Hôpital Henri Duffaut
Contact:
Olivier BOULAT, Dr
OBoulat@ch-avignon.fr
Bayeux CEDEX, France, 14401

Recruiting

Hôpital de Bayeux
Contact:
Annie PEYTIER, Dr
a.peytier@sih-bessin.fr
Bayonne CEDEX, France, 64109

Recruiting

CH Côte Basque
Contact:
Franck AUDEMAR, Dr
faudemar@ch-cotebasque.fr
Bayonne, France, 64100

Recruiting

Centre d'Oncologie et de Radiothérapie du Pays-Basque
Contact:
Stéphane REMY, Dr
stephane.remy@oncologie-pays-basque.org
Beauvais, France, 60021

Recruiting

CH de Beauvais
Contact:
Fayçal HOCINE, Dr
f.hocine@ch-beauvais.fr ; fayoncologie@yahoo.fr
Blois, France, 41000

Recruiting

CH de Blois
Contact:
Dany GARGOT, Dr
dgargot@ch-blois.fr
BOBIGNY cedex, France, 93009

Recruiting

CHU Avicenne
Contact:
Thomas APARICIO, Pr
01 48 95 54 31
thomas.aparicio@avc.aphp.fr
Contact:
Mourad BENALLAOUA
01 48 95 54 31
thomas.aparicio@avc.aphp.fr
Principal Investigator:
Thomas APARICIO
Sub-Investigator:
Florence MARY
Bordeaux CEDEX, France, 33077

Recruiting

Polyclinique Bordeaux Nord
Contact:
Cédric LECAILLE, Dr
lecail@hotmail.com; m.balhadere@hotmail.fr
Boulogne-sur-Mer, France, 62321

Recruiting

Hôpital Duchenne
Contact:
Vincent BOURGEOIS, Dr
vincebourgeois@hotmail.com
Bourgoin-Jallieu, France, 38300

Recruiting

Hôpital Pierre Oudot
Contact:
Benoit AVISSE, Dr
benoit.avisse@club-internet.fr;bavisse@ch-bourgoin.fr
Brest, France, 29200

Recruiting

Clinique Pasteur Saint Esprit
Contact:
Véronique JESTIN LE TALLEC, Dr
veronique.jestin-letallec@orange.fr
Béziers, France, 34525

Recruiting

CH de Béziers
Contact:
Mohamed RAMDANI, Dr
mohamed.ramdani@ch-beziers.fr
Caen, France, 14033

Recruiting

CHU Côte de Nacre
Contact:
Karine BOUHIER LEPORRIER, Dr
bouhierleporrier-k@chu-caen.fr
Cahors, France

Recruiting

CH
Contact:
Nadia LEVASSEUR
nadia.levasseur@ch-cahors.fr
Principal Investigator:
Nadia LEVASSEUR
Caluire-et-Cuire, France, 69300

Recruiting

Infirmerie Protestante de Lyon
Contact:
Johannes HARTWIG, Dr
johannes.hartwig@infirmerie-protestante.com
Chalon-sur-Saône, France, 71100

Recruiting

CH William Morey
Contact:
Laurie RAMBACH, Dr
laurie.rambach@ch-chalon71.fr
Chalon-sur-Saône, France, 71100

Recruiting

Hôpital Privé Sainte Marie
Contact:
Adrien MELIS, Dr
melisadrien@yahoo.fr
Chambery CEDEX, France, 73011

Recruiting

Centre Hospitalier Métropole Savoie
Contact:
Jocelyne PROVENCAL, Dr
jocelyne.provencal@ch-metropole-savoie.fr
Cherbourg, France, 50102

Recruiting

Centre Hospitalier Public du Cotentin
Contact:
Laure KALUZINSKI, Dr
recherche-clinique@ch-cotentin.fr
Cherbourg, France

Recruiting

CH
Contact:
Laure KALUZINSKI
l.kaluzinski@ch-cherbourg.fr
Principal Investigator:
Laure KALUZINSKI
Sub-Investigator:
Arm ELWESHI
Sub-Investigator:
Jean-Nicolas PINHO
Châlons-en-Champagne, France, 51005

Recruiting

Centre Hospitalier Général
Contact:
Naceur ABDELLI, Dr
nabdelli@ch-chalonsenchampagne.fr; docteurnaceurabdelli@gmail.com
Clermont-Ferrand, France, 63003

Recruiting

CHU Estaing
Contact:
Caroline PETORIN, Dr
cpetorin@chu-clermontferrand.fr
Colmar, France, 68024

Recruiting

Hopitaux Civils de Colmar
Contact:
Gilles BREYSACHER, Dr
gilles.breysacher@ch-colmar.fr
Compiègne CEDEX, France, 60321

Recruiting

Centre Hospitalier
Contact:
Jean-Christophe DUCHMANN, Dr
jc.duchmann@ch-compiegnenoyon.fr
Contamine sur Arve, France

Recruiting

CH
Contact:
Carol ALLIOT
calliot@ch-alpes-leman.fr
Principal Investigator:
Carol ALLIOT
Corbeil-Essonnes, France, 91106

Recruiting

Centre Hospitalier Sud Francilien
Contact:
Samy LOUAFI, Dr
samy.louafi@gmail.com; samy.louafi@chsf.fr
Cornebarrieu, France, 31700

Recruiting

Clinique des Cèdres
Contact:
Isabelle ROQUE, Dr
isa.roque@wanadoo.fr
Cornebarrieu, France

Recruiting

Clinique des Cèdres
Contact:
Isabelle ROQUE
isa.roque@wanadoo.fr
Principal Investigator:
Isabelle ROQUE
Sub-Investigator:
Alain LEDIT
Dax CEDEX, France, 40107

Recruiting

Centre Hospitalier de Dax
Contact:
Laure GAUTIER FELIZOT, Dr
gautier-felizot@ch-dax.fr
Digne-les-Bains, France, 04000

Recruiting

Service de médecine
Contact:
Gilbert BORDES, Dr
gbordes@ch-digne.fr
Dijon CEDEX, France, 21079

Recruiting

Hôpital François Mitterand
Contact:
Côme LEPAGE, Pr
come.lepage@u-bourgogne.fr
Dijon, France, 21000

Recruiting

Institut de Cancérologie de Bourgogne - GRRECC
Contact:
Geneviève BOILLEAU-JOLIMOY, Dr
gjolimoy@icb-cancer.fr; gjolimoy@yahoo.fr
Dijon, France, 21079

Recruiting

Centre Goerges François Leclerc
Contact:
Leila BENGRINE LEFEVRE, Dr
lbengrine@cgfl.fr
Elbeuf, France, 76503

Recruiting

CHI Elbeuf-Louviers-Val de Reuil
Contact:
Anne-Marie QUENIET, Dr
anne-marie.queuniet@chi-elbeuf-louviers.fr
Flers, France

Recruiting

CH
Contact:
Pierre-Emmanuel HENNERESSE
pierre-emmanuel.henneresse@ch-flers.fr ; netpeh@orange.fr
Principal Investigator:
Pierre-Emmanuel HENNERESSE
Sub-Investigator:
Laurent LION
Fréjus, France, 83600

Recruiting

CHI de Fréjus Saint-Raphaël
Contact:
Bruno VALENZA, Dr
valenza-b@chi-frejus-saint-raphael.fr;oncologie-sec@chi-fsr.fr; brunovalenza@msn.com
Férolles-Attilly, France, 77150

Recruiting

Centre médical des Forcilles
Contact:
Hélène DALL OSTO, Dr
hdallosto@cognacq-jay.fr
Gap, France, 05007

Recruiting

Centre Hospitalier
Contact:
Olivier GUILLEM, Dr
olivier.guillem@chicas-gap.fr; olivier.guillem@gmail.com
Gonesse, France, 95500

Recruiting

Centre Hospitalier
Contact:
Yacine HADJARAB, Mr
yacine.hadjarab@wanadoo.fr
Gonesse, France

Recruiting

CH
Principal Investigator:
Sabri AHMED
Grenoble CEDEX, France, 38043

Recruiting

CHU de Grenoble - Hôpital A. Michallon
Contact:
Jean-Luc FAUCHERON, Pr
jlfaucheron@chu-grenoble.fr
Jossigny, France, 77600

Recruiting

CH Marne La Vallée-Jossigny
Contact:
Christine LE FOLL, Dr
clefoll@ch-marnelavallee.fr
La Roche-sur-Yon, France, 85925

Recruiting

CHD Vendée
Contact:
Roger FAROUX, Dr
roger.faroux@chd-vendee.fr
La Rochelle, France, 17019

Recruiting

Groupe Hospitalier de la Rochelle Ré-Aunis
Contact:
Marie BRECHON, Dr
marie.brechon@ch-larochelle.fr
Le Coudray, France

Recruiting

CH
Contact:
Gabriela TOSSEN
gtossen@hotmail.com
Principal Investigator:
Gabriela TOSSEN
Sub-Investigator:
Michèle MANGOLD
Le Mans CEDEX 9, France, 72037

Recruiting

CH du Mans
Contact:
Oana COJOCARASU, Dr
ocojocarasu@ch-lemans.fr; oanaalexa@hotmail.com
Lille, France, 59037

Recruiting

Centre Oscar Lambret
Contact:
Farid EL HAJBI, Dr
f-elhajbi@o-lambret.fr
Lille, France, 59037

Recruiting

CHRU Hôpital Claude Huriez 4eme EST
Contact:
Anthony TURPIN, Dr
turpin.anth@yahoo.fr; anthony.turpin@chru-lille.fr
Limoges, France, 87000

Recruiting

Clinique François Chénieux
Contact:
Jean MARTIN, Dr
jm@imagemed-87.com
Limoges, France, 87042

Recruiting

CHU Dupuytren
Contact:
Valérie LE BRUN LY, Dr
valerie.lebrun@chu-limoges.fr
Longjumeau, France, 91164

Recruiting

CH
Contact:
Joël EZENFIS, Dr
joel.ezenfis@ch-longjumeau.fr
Lorient CEDEX, France, 56322

Recruiting

CHBS - Hôpital du Scorff
Contact:
Joëlle EGRETEAU, Dr
j.egreteau@ch-bretagne-sud.fr
Lyon CEDEX 09, France, 69009

Recruiting

Clinique de la Sauvegarde
Contact:
Isabelle MOULLET, Dr
i.moullet@wanadoo.fr
Lyon, France, 69003

Recruiting

Clinique Mutualiste Eugène André
Contact:
Cécile FOURNEL, Dr
cecile.fournel@icloire.fr
Lyon, France, 69008

Recruiting

Hôpital Privé Jean Mermoz
Contact:
Jérôme DESRAME, Pr
jerome.desrame@orange.fr
Lyon, France, 69317

Recruiting

CHU de Lyon - Croix Rousse
Contact:
Marielle GUILLET, Dr
marielle.guillet@chu-lyon.fr; marielguillet@hotmail.fr; celine.leclercq@chu-lyon.fr
Lyon, France, 69365

Recruiting

CH ST Joseph-ST Luc
Contact:
Denis PERE VERGE, Dr
dpereverge@ch-stjoseph-stluc-lyon.fr; fannydenis@sfr.fr
Lyon, France, 69437

Recruiting

Hôpital Edouard Herriot
Contact:
Julien FORESTIER, Dr
julien.forestier@chu-lyon.fr
Macon, France

Recruiting

Centre Radiologie
Contact:
Isabelle POUCHARD
rthmacon@orange.fr; iporlem@orange.fr
Principal Investigator:
Isabelle POUCHARD
Sub-Investigator:
Fabrice LORCHEL
Sub-Investigator:
Nicolas BARBET
Marseille CEDEX 03, France, 13331

Recruiting

Hôpital Européen Marseille
Contact:
Yves RINALDI, Dr
y.rinaldi@hopital-europeen.fr; yrinaldi@wanadoo.fr
Marseille CEDEX 20, France, 13915

Recruiting

Hopital Nord
Contact:
Mohamed GASMI, Dr
mohamed.gasmi@ap-hm.fr
Marseille CEDEX 5, France, 13385

Recruiting

CHU La Timone
Contact:
Laétitia DAHAN, Pr
laetitia.dahan@ap-hm.fr
Meaux, France, 77100

Recruiting

CH de Meaux
Contact:
Christophe LOCHER, Dr
c-locher@ch-meaux.fr
Mont-de-Marsan, France, 40024

Recruiting

Hôpital Layne
Contact:
Jérôme DAUBA, Dr
jerome.dauba@ch-mt-marsan.fr
Montivilliers, France, 76290

Recruiting

Hôpital Monod
Contact:
Charline MARRE, Dr
charline.marre@ch-havre.fr; charlinemarre@gmail.com
Montélimar, France, 26216

Recruiting

Centre Hospitalier
Contact:
Agnès PELAQUIER, Dr
agnes.pelaquier@ch-montelimar.fr; agnes.pelaquier@free.fr
Morlaix CEDEX, France, 29672

Recruiting

Centre Hospitalier
Contact:
Marc FEREC, Dr
mferec@ch-morlaix.fr; marc_ferec@hotmail.com
Mougins, France, 06250

Recruiting

Centre Azuréen de Cancérologie
Contact:
Benjamin HOCH, Dr
dr.bhoch@gmail.com
Nantes, France, 44277

Recruiting

Hôpital Privé du Confluent SAS
Contact:
Hélène CASTANIE, Dr
helene.castanie@groupeconfluent.fr
Neuilly-sur-Seine, France, 92200

Recruiting

Hôpital Américain de Paris
Contact:
Lionel VEDRINE, Pr
lionelvedrine@orange.fr
Nevers CEDEX, France, 58033

Recruiting

Hôpital Pierre Bérégovoy
Contact:
Abdelkader OUAZIR, Dr
abdelkader.ouazir@ch-nevers.fr
Nice CEDEX 2, France, 06189

Recruiting

Centre Antoine Lacassagne
Contact:
Eric FRANCOIS, Dr
eric.francois@nice.unicancer.fr
Nîmes CEDEX 9, France, 30029

Recruiting

Centre Oncogard
Contact:
Jacques CRETIN, Dr
cretinjacques@yahoo.fr
Nîmes, France, 30029

Recruiting

CHU Carémeau
Contact:
Valérie PHOUTTHASANG, Dr
Valivalo@hotmail.com
Orléans CEDEX 2, France, 45067

Recruiting

Hôpital de la Source
Contact:
Jean-Paul LAGASSE, Dr
jean-paul.lagasse@chr-orleans.fr
Paris, France, 75013

Recruiting

Hôpital Privé des Peupliers
Contact:
Mustapha ZOUBIR, Dr
m.zoubir@gsante.fr
Paris, France, 75571

Recruiting

Hôpital Saint Antoine
Contact:
Daniel LOPEZ-TRABADA, Dr
daniel.lopez-trabada-ataz@aphp.fr
Paris, France

Recruiting

HEGP
Contact:
Julien TAIEB
julien.taieb@egp.aphp.fr; jtaieb75@gmail.com
Principal Investigator:
Julien TAIEB
Sub-Investigator:
Céline LEPERE
Sub-Investigator:
Bruno LANDI
Sub-Investigator:
Anne-Laure POINTET
Sub-Investigator:
Géraldine PERKINS
Sub-Investigator:
Aziz ZAANAN
Sub-Investigator:
Jean-Nicolas VAILLANT
Sub-Investigator:
Jeanne NETTER
Sub-Investigator:
Simon PERNOT
Paris, France

Recruiting

Hôpital Cochin
Contact:
Romain CORIAT
romain.coriat@cch.aphp.fr
Principal Investigator:
Romain CORIAT
Sub-Investigator:
Marion DHOOGE
Sub-Investigator:
Johann DREANIC
Sub-Investigator:
Jean-Marie TIGAUD
Sub-Investigator:
Catherine BREZAULT
Paris, France

Recruiting

Hôpital Saint Louis
Contact:
Jean-Marc GORNET
jean-marc.gornet@sls.aphp.fr
Principal Investigator:
Jean-Marc GORNET
Paris, France

Recruiting

Institut Montsouris
Contact:
Christophe LOUVET
christophe.louvet@imm.fr
Principal Investigator:
Christophe LOUVET
Sub-Investigator:
Mostefa BENNANMOUN
Sub-Investigator:
Jean-Luc MOLITOR
Paris, France

Recruiting

Pitié Salpêtière
Contact:
Olivier DUBREUIL
olivier.dubreuil@aphp.fr
Principal Investigator:
Olivier DUBREUIL
Sub-Investigator:
Jean-Baptiste BACHET
Sub-Investigator:
Solène DOAT
Pau CEDEX, France, 64046

Recruiting

Centre Hospitalier
Contact:
Juliette THAURY, Dr
juliette.thaury@ch-pau.fr; jthaury@yahoo.fr
Pessac CEDEX, France, 33604

Recruiting

Hôpital Haut Leveque
Contact:
Eric TERREBONNE, Dr
eric.terrebonne@chu-bordeaux.fr
Pierre-Bénite, France, 64495

Recruiting

CHU Lyon Sud
Contact:
Claire FALANDRY, Dr
claire.falandry@chu-lyon.fr
Plérin, France, 22190

Recruiting

Centre CARIO - HCPA
Contact:
Pierre-Luc ETIENNE, Dr
pl.etienne@cario-sante.fr ; pl.etienne@wanadoo.fr
Poitiers, France, 86021

Recruiting

Hôpital de la Milétrie
Contact:
David TOUGERON, Pr
david.tougeron@chu-poitiers.fr
Pringy, France, 74374

Recruiting

CH Annecy Genevois
Contact:
Emmanuel MAILLARD, Dr
emaillard@ch-annecygenevois.fr
Périgueux, France, 24004

Recruiting

Polyclinique Francheville
Contact:
Laurent CANY, Dr
l.cany@oncoradio24.com
Reims CEDEX, France, 51092

Recruiting

CHU Robert Debré
Contact:
Olivier BOUCHE, Pr
obouche@chu-reims.fr
Rennes CEDEX 9, France, 35033

Recruiting

CHU de Pontchaillou
Contact:
Astrid LIEVRE, Pr
astrid.lievre@chu-rennes.fr
Rennes CEDEX, France, 35042

Recruiting

Centre Eugène Marquis
Contact:
Astrid LIEVRE, Dr
astrid.lievre@chu-rennes.fr
Rodez, France

Recruiting

CH
Contact:
Laurent MOSSER
l.mosser@ch-rodez.fr
Principal Investigator:
Laurent MOSSER
Romans-sur-Isère, France, 26100

Recruiting

Hôpital Drome Nord
Contact:
Marie-Claude GOUTTEBEL, Dr
mc.gouttebel@hopitaux-drome-nord.fr
Rouen CEDEX 01, France, 76031

Recruiting

CHU Charles Nicolle
Contact:
David SEFRIOUI, Dr
david.sefrioui@chu-rouen.fr
Rouen CEDEX, France, 76175

Recruiting

Clinique Mathilde
Contact:
Sakher ALADEN, Dr
Saint Gregoire, France, 35768

Recruiting

Hôpital Privé Saint Grégoire
Contact:
Anne MERCIER BLAS, Dr
amercierblas@vivalto-sante.com
Saint Herblain, France, 44805

Recruiting

ICO - Site René Gauducheau
Contact:
Sandrine HIRET, Dr
Sandrine.hiret@ico.unicancer.fr
Saint Priest en Jarez, France, 42271

Recruiting

Institut de Cancérologie Lucien Neuwirth
Contact:
Jean-Marc PHELIP, Pr
j.marc.phelip@chu-st-etienne.fr
Saint Quentin, France

Recruiting

CH
Contact:
Innocenti DADAMESSI
I.dadamessi@ch-stquentin.fr;dadamessi@gmail.com
Principal Investigator:
Innocenti DADAMESSI
Saint-Cloud, France, 92210

Recruiting

Institut Curie
Contact:
Amani ASNACIOS-LECERF, Dr
amaniasnacios@yahoo.fr; amani.asnacioslecerf@curie.fr
Saint-Jean-de-Luz, France, 64500

Recruiting

Polyclinique Côte Basque Sud
Contact:
Etienne MAURIAC, Dr
etiennemauriac@gmail.com
Saint-Malo, France, 35403

Recruiting

Centre Hospitalier de Saint-Malo
Contact:
Romain DESGRIPPES, Dr
r.desgrippes@ch-stmalo.fr
Saint-Mandé, France, 94163

Recruiting

Hôpital d'Instruction des Armées Begin
Contact:
Serge CREMADES, Pr
cremades.sa@club-internet.fr
Saint-Quentin, France, 02100

Recruiting

Polyclinique Saint Claude
Contact:
Pierre VANELSLANDER, Dr
vanelspi@gmail.com
Saintes, France, 17108

Recruiting

CH Saintonge
Contact:
Florence BORDE-MOUGENOT, Dr
3C@ch-saintonge.fr; f.borde@ch-saintonge.fr
Semur-en-Auxois, France, 21140

Recruiting

CH Morlevat
Contact:
Arnaud PATENOTTE, Dr
arnaud.patenotte@ch-semur-en-auxois.fr
Senlis CEDEX, France, 60309

Recruiting

CH
Contact:
Elisabeth CAROLA, Dr
elisabeth.carola@ghpso.fr
Sens CEDEX, France, 89108

Recruiting

Centre Hospitalier
Contact:
Hélène COSME GASSMANN, Dr
hcosme@ch-sens.fr
St Omer, France, 62505

Recruiting

CH Région Saint Omer
Contact:
Claire CAPELLE, Dr
c.capelle@ch-boulogne.fr; claire.capelle@gmx.fr
Strasbourg, France, 67000

Recruiting

Clinique Sainte Anne
Contact:
Louis-Marie DOURTHE, Dr
lm.dourthe@solcrr.org
Strasbourg, France, 67065

Recruiting

Centre Paul Strauss
Contact:
Meher BEN ABDELGHANI, Dr
mbenabdelghani@strasbourg.unicancer.fr
Thonon-les-Bains, France, 74203

Recruiting

Hôpitaux du Leman
Contact:
Ahmed BEDJAOUI, Dr
a-bedjaoui@ch-hopitauxduleman.fr
Toulon, France, 83000

Recruiting

Hôpital Sainte Musse
Contact:
Frédéric VIRET, Dr
frederic.viret@ch-toulon.fr
Toulon, France, 83000

Recruiting

Hôpital Sainte Musse
Contact:
Camille SIBERTIN-BLANC, Dr
camille.sibertin-blanc@ch-toulon.fr
Toulouse, France, 31077

Recruiting

Clinique Saint Jean du Languedoc
Contact:
Etienne Suc, Dr
esucsjl@club-internet.fr
Tours CEDEX 9, France, 37044

Recruiting

Hôpitaux Trousseau
Contact:
Thierry LECOMTE, Pr
thierry.lecomte@med.univ-tours.fr
Valenciennes, France, 59322

Recruiting

Centre Hospitalier
Contact:
Isabelle BONNET, Dr
bonnet-i@ch-valenciennes.fr
Vandoeuvre les nancy, France, 54511

Recruiting

CHU de Nancy-Bradois
Contact:
Anthony LOPEZ, Dr
anthony-lopez@hotmail.fr; a.lopez@chru-nancy.fr
Vandoeuvre les nancy, France, 54519

Recruiting

Institut de Cancérologie de Lorraine
Contact:
Marie-Christine KAMINSKY, Dr
mc.kaminsky@nancy.unicancer.fr
Villejuif, France

Recruiting

Paul Brousse
Contact:
Anne THIROT-BIDAULT
anne.bidault@bct.aphp.fr
Principal Investigator:
Anne THIROT-BIDAULT
Villeneuve-Saint-Georges, France, 94195

Recruiting

Centre Hospitalier
Contact:
Linda BOUAITA, Dr
lindabouaita@yahoo.fr
Guadeloupe Locations
Fort De France, Guadeloupe, France, 97261

Recruiting

CHU de Fort de France
Contact:
Nathalie GROSSAT BERNADOU, Dr
nathalie.grossat-bernadou@chu-martinique.fr
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  • Age ≥ 70 years
  • Patient considered able to receive chemotherapy
  • Lee score detailed faxed to CRGA
  • Stage III colon adenocarcinoma
  • R0 resection of the primary tumor
  • Start of the potential adjuvant chemotherapy within 12 weeks after surgery
  • No prior chemotherapy for colon cancer
  • Geriatric Self-administered questionnaire completed faxed to CRGA
  • Geriatric Questionnaire completed by the team faxed to CRGA
  • Effective contraception for men patients throughout treatment and for at least 6 months after discontinuation of oxaliplatin
  • Consent signed

Exclusion Criteria:

  • Other progressive disease (cancer uncontrolled for less than 2 years)
  • Rectal Cancer (located less than 15 cm from the anal verge endoscopy or sub-peritoneal)
  • ANC <2000 / mm3 for group 1 and ANC <1500 / mm3 for group 2 and platelets <100,000 / mm3 or hemoglobin <9 g / dL
  • Neuropathy for patients in group 1
  • Known deficit of dihydropyrimidine dehydrogenase (DPD)
  • Patients with severe hepatic insufficiency
  • Any contrindication to the drugs used in the study
  • Inability to submit to medical follow-up for geographical, social or psychological reasons.
Show less
Ages Eligible for Study
75 Years and older (Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: GROUP1 -ARM A
LV5FU2 or capecitabine
Intervention/Treatment Drug: LV5FU2 or capectitabine
Participant Group/Arm Experimental: GROUP1-ARMB
FOLFOX4 or XELOX
Intervention/Treatment Drug: FOLFOX4 or XELOX
Participant Group/Arm Experimental: GROUP2- ARM C
Observation
Intervention/Treatment Other: Observation
Participant Group/Arm Experimental: GROUP2-ARM D
LV5FU2 or capecitabine
Intervention/Treatment Drug: LV5FU2 or capecitabine
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
The 3-year disease-free survival 3 years after last patient in
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Overal survival 5 years after last patient in
Observed toxicities, graded according to NCI-CTC v4 3 years after last patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Federation Francophone de Cancerologie Digestive
Investigators
  • Principal Investigator:Thomas Aparicio, Pr,FFCD member

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2015-01-26
First Submitted that Met QC Criteria
2015-02-03
First Posted (Estimated)
2015-02-04
Study Record Updates
Last Update Submitted that met QC Criteria
2024-07-05
Last Update Posted
2024-07-08
Last Verified
2024-07

More Information

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Keywords Provided by Federation Francophone de Cancerologie Digestive
Additional Relevant MeSH Terms