AzTrials
AzTrials

Colonic AdenocarcinomaPhase 3ADAGENCT02355379

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

A Phase 3 study testing LV5FU2 or capectitabine, FOLFOX4 or XELOX and Observation in people with Colonic Adenocarcinoma, run by Federation Francophone de Cancerologie Digestive at 140 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Colonic Adenocarcinoma
What is being tested?
LV5FU2 or capectitabine, FOLFOX4 or XELOX and Observation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
774 participants
Where
140 sitesFrance
Study dates
Jan 2015to Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

140 sites in 1 country.

Martina Schneider contact

+33 3 80 39 34 83

martina.schneider@u-bourgogne.fr

Jaique Cario contact

+33 3 80 39 34 86

jaique.cario_isat@u-bourgogne.fr

140 sites in 1 country

France140 sites, 140 recruiting

  • CH d'Abbeville

    Abbeville, 80142

    Mathieu PAUWELS, Dr, pauwels.mathieu@ch-abbeville.fr; pauwels.gastro@wanadoo.fr

    Recruiting

  • CROMG

    Agen

    Adela CAUCHOIS, 05 53 69 12 00

    Adela CAUCHOIS

    Recruiting

  • Centre hospitalier du Pays d'Aix

    Aix-en-Provence, 13616

    Sophie NAHON BRISSONNEAU, Dr, arc.emrc13@gmail.com

    Recruiting

  • Centre hospitalier d'Albi

    Albi, 81000

    Nadia MUNSCH, Dr, nadia.munsch@ch-albi.rss.fr

    Recruiting

  • Clinique Claude Bernard

    Albi, 81030

    Yann BERGE, Dr, berge@claude-bernard-albi.com

    Recruiting

  • Clinique Claude Bernard

    Albi

    Yann BERGE, berge@claude-bernard-albi.com

    Yann BERGE

    Recruiting

  • Centre Oncogard

    Alès, 30103

    Jacques CRETIN, Dr, cretinjacques@yahoo.fr

    Recruiting

  • Hôpital Sud

    Amiens, 80054

    Vincent HAUTEFEUILLE, Dr, hautefeuille.vincent@chu-amiens.fr

    Recruiting

  • ICO Site Paul Papin

    Angers, 49055

    Sandrine HIRET, Dr, Sandrine.hiret@ico.unicancer.fr

    Recruiting

  • CHU d'Angers

    Angers, 49933

    Nathalie BAIZE, Dr, nabaize@chu-angers.fr

    Recruiting

  • HOP Privé

    Annemasse

    Oxana SHESTAEVA, o.shestaeva@ramsaygds.fr

    Oxana SHESTAEVA

    Recruiting

  • CH Victor Dupouy

    Argenteuil, 95107

    Arnaud BOUTAN-LAROZE, Dr, arnaud.boutan-laroze@ch-argenteuil.fr

    Recruiting

  • Hôpital Les Bonnettes

    Arras, 62012

    Bruno HUGUENIN, Dr, drbhuguenin@orange.fr

    Recruiting

  • Hôpital Privé Bonnettes

    Arras

    Bruno HUGUENIN, drbhuguenin@orange.fr

    Bruno HUGUENIN

    Recruiting

  • Centre Hospitalier Ardèche Méridionale

    Aubenas, 07205

    Brigitte VELAY, Dr, brigitte.velay@ch-ardeche-meridionale.fr

    Recruiting

  • CH D'Auxerre

    Auxerre, 89000

    Anne-Laure VILLING, Dr, alvilling@ch-auxerre.fr

    Recruiting

  • Hôpital Henri Duffaut

    Avignon, 84902

    Olivier BOULAT, Dr, OBoulat@ch-avignon.fr

    Recruiting

  • Institut Sainte Catherine

    Avignon, 84918

    Laurent MINEUR, Dr, l.mineur@isc84.org

    Recruiting

  • Hôpital de Bayeux

    Bayeux, 14401

    Annie PEYTIER, Dr, a.peytier@sih-bessin.fr

    Recruiting

  • Centre d'Oncologie et de Radiothérapie du Pays-Basque

    Bayonne, 64100

    Stéphane REMY, Dr, stephane.remy@oncologie-pays-basque.org

    Recruiting

  • CH Côte Basque

    Bayonne, 64109

    Franck AUDEMAR, Dr, faudemar@ch-cotebasque.fr

    Recruiting

  • CH de Beauvais

    Beauvais, 60021

    Fayçal HOCINE, Dr, f.hocine@ch-beauvais.fr ; fayoncologie@yahoo.fr

    Recruiting

  • CH de Béziers

    Béziers, 34525

    Mohamed RAMDANI, Dr, mohamed.ramdani@ch-beziers.fr

    Recruiting

  • CH de Blois

    Blois, 41000

    Dany GARGOT, Dr, dgargot@ch-blois.fr

    Recruiting

  • CHU Avicenne

    Bobigny, 93009

    Thomas APARICIO, Pr, 01 48 95 54 31, thomas.aparicio@avc.aphp.fr

    Mourad BENALLAOUA, 01 48 95 54 31, thomas.aparicio@avc.aphp.fr

    Recruiting

  • Polyclinique Bordeaux Nord

    Bordeaux, 33077

    Cédric LECAILLE, Dr, lecail@hotmail.com; m.balhadere@hotmail.fr

    Recruiting

  • Hôpital Duchenne

    Boulogne-sur-Mer, 62321

    Vincent BOURGEOIS, Dr, vincebourgeois@hotmail.com

    Recruiting

  • Hôpital Pierre Oudot

    Bourgoin, 38300

    Benoit AVISSE, Dr, benoit.avisse@club-internet.fr;bavisse@ch-bourgoin.fr

    Recruiting

  • Clinique Pasteur Saint Esprit

    Brest, 29200

    Véronique JESTIN LE TALLEC, Dr, veronique.jestin-letallec@orange.fr

    Recruiting

  • CHU Côte de Nacre

    Caen, 14033

    Karine BOUHIER LEPORRIER, Dr, bouhierleporrier-k@chu-caen.fr

    Recruiting

  • CH

    Cahors

    Nadia LEVASSEUR, nadia.levasseur@ch-cahors.fr

    Nadia LEVASSEUR

    Recruiting

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69300

    Johannes HARTWIG, Dr, johannes.hartwig@infirmerie-protestante.com

    Recruiting

  • CH William Morey

    Chalon-sur-Saône, 71100

    Laurie RAMBACH, Dr, laurie.rambach@ch-chalon71.fr

    Recruiting

  • Hôpital Privé Sainte Marie

    Chalon-sur-Saône, 71100

    Adrien MELIS, Dr, melisadrien@yahoo.fr

    Recruiting

  • Centre Hospitalier Général

    Châlons-en-Champagne, 51005

    Naceur ABDELLI, Dr, nabdelli@ch-chalonsenchampagne.fr; docteurnaceurabdelli@gmail.com

    Recruiting

  • Centre Hospitalier Métropole Savoie

    Chambéry, 73011

    Jocelyne PROVENCAL, Dr, jocelyne.provencal@ch-metropole-savoie.fr

    Recruiting

  • Centre Hospitalier Public du Cotentin

    Cherbourg, 50102

    Laure KALUZINSKI, Dr, recherche-clinique@ch-cotentin.fr

    Recruiting

  • CH

    Cherbourg

    Laure KALUZINSKI, l.kaluzinski@ch-cherbourg.fr

    Laure KALUZINSKI

    Recruiting

  • CHU Estaing

    Clermont-Ferrand, 63003

    Caroline PETORIN, Dr, cpetorin@chu-clermontferrand.fr

    Recruiting

  • Hopitaux Civils de Colmar

    Colmar, 68024

    Gilles BREYSACHER, Dr, gilles.breysacher@ch-colmar.fr

    Recruiting

  • Centre Hospitalier

    Compiègne, 60321

    Jean-Christophe DUCHMANN, Dr, jc.duchmann@ch-compiegnenoyon.fr

    Recruiting

  • CH

    Contamine-sur-Arve

    Carol ALLIOT, calliot@ch-alpes-leman.fr

    Carol ALLIOT

    Recruiting

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106

    Samy LOUAFI, Dr, samy.louafi@gmail.com; samy.louafi@chsf.fr

    Recruiting

  • Clinique des Cèdres

    Cornebarrieu, 31700

    Isabelle ROQUE, Dr, isa.roque@wanadoo.fr

    Recruiting

  • Clinique des Cèdres

    Cornebarrieu

    Isabelle ROQUE, isa.roque@wanadoo.fr

    Isabelle ROQUE

    Recruiting

  • Centre Hospitalier de Dax

    Dax, 40107

    Laure GAUTIER FELIZOT, Dr, gautier-felizot@ch-dax.fr

    Recruiting

  • Service de médecine

    Digne-les-Bains, 04000

    Gilbert BORDES, Dr, gbordes@ch-digne.fr

    Recruiting

  • Institut de Cancérologie de Bourgogne - GRRECC

    Dijon, 21000

    Geneviève BOILLEAU-JOLIMOY, Dr, gjolimoy@icb-cancer.fr; gjolimoy@yahoo.fr

    Recruiting

  • Centre Goerges François Leclerc

    Dijon, 21079

    Leila BENGRINE LEFEVRE, Dr, lbengrine@cgfl.fr

    Recruiting

  • Hôpital François Mitterand

    Dijon, 21079

    Côme LEPAGE, Pr, come.lepage@u-bourgogne.fr

    Recruiting

  • CHI Elbeuf-Louviers-Val de Reuil

    Elbeuf, 76503

    Anne-Marie QUENIET, Dr, anne-marie.queuniet@chi-elbeuf-louviers.fr

    Recruiting

  • Centre médical des Forcilles

    Férolles-Attilly, 77150

    Hélène DALL OSTO, Dr, hdallosto@cognacq-jay.fr

    Recruiting

  • CH

    Flers

    Pierre-Emmanuel HENNERESSE, pierre-emmanuel.henneresse@ch-flers.fr ; netpeh@orange.fr

    Pierre-Emmanuel HENNERESSE

    Recruiting

  • CHU de Fort de France

    Fort de France, Guadeloupe, 97261

    Nathalie GROSSAT BERNADOU, Dr, nathalie.grossat-bernadou@chu-martinique.fr

    Recruiting

  • CHI de Fréjus Saint-Raphaël

    Fréjus, 83600

    Bruno VALENZA, Dr, valenza-b@chi-frejus-saint-raphael.fr;oncologie-sec@chi-fsr.fr; brunovalenza@msn.com

    Recruiting

  • Centre Hospitalier

    Gap, 05007

    Olivier GUILLEM, Dr, olivier.guillem@chicas-gap.fr; olivier.guillem@gmail.com

    Recruiting

  • Centre Hospitalier

    Gonesse, 95500

    Yacine HADJARAB, Mr, yacine.hadjarab@wanadoo.fr

    Recruiting

  • CH

    Gonesse

    Sabri AHMED

    Recruiting

  • CHU de Grenoble - Hôpital A. Michallon

    Grenoble, 38043

    Jean-Luc FAUCHERON, Pr, jlfaucheron@chu-grenoble.fr

    Recruiting

  • CH Marne La Vallée-Jossigny

    Jossigny, 77600

    Christine LE FOLL, Dr, clefoll@ch-marnelavallee.fr

    Recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85925

    Roger FAROUX, Dr, roger.faroux@chd-vendee.fr

    Recruiting

  • Groupe Hospitalier de la Rochelle Ré-Aunis

    La Rochelle, 17019

    Marie BRECHON, Dr, marie.brechon@ch-larochelle.fr

    Recruiting

  • CH

    Le Coudray

    Gabriela TOSSEN, gtossen@hotmail.com

    Gabriela TOSSEN

    Recruiting

  • CH du Mans

    Le Mans, 72037

    Oana COJOCARASU, Dr, ocojocarasu@ch-lemans.fr; oanaalexa@hotmail.com

    Recruiting

  • Centre Oscar Lambret

    Lille, 59037

    Farid EL HAJBI, Dr, f-elhajbi@o-lambret.fr

    Recruiting

  • CHRU Hôpital Claude Huriez 4eme EST

    Lille, 59037

    Anthony TURPIN, Dr, turpin.anth@yahoo.fr; anthony.turpin@chru-lille.fr

    Recruiting

  • Clinique François Chénieux

    Limoges, 87000

    Jean MARTIN, Dr, jm@imagemed-87.com

    Recruiting

  • CHU Dupuytren

    Limoges, 87042

    Valérie LE BRUN LY, Dr, valerie.lebrun@chu-limoges.fr

    Recruiting

  • CH

    Longjumeau, 91164

    Joël EZENFIS, Dr, joel.ezenfis@ch-longjumeau.fr

    Recruiting

  • CHBS - Hôpital du Scorff

    Lorient, 56322

    Joëlle EGRETEAU, Dr, j.egreteau@ch-bretagne-sud.fr

    Recruiting

  • Clinique Mutualiste Eugène André

    Lyon, 69003

    Cécile FOURNEL, Dr, cecile.fournel@icloire.fr

    Recruiting

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

    Jérôme DESRAME, Pr, jerome.desrame@orange.fr

    Recruiting

  • Clinique de la Sauvegarde

    Lyon, 69009

    Isabelle MOULLET, Dr, i.moullet@wanadoo.fr

    Recruiting

  • CHU de Lyon - Croix Rousse

    Lyon, 69317

    Marielle GUILLET, Dr, marielle.guillet@chu-lyon.fr; marielguillet@hotmail.fr; celine.leclercq@chu-lyon.fr

    Recruiting

  • CH ST Joseph-ST Luc

    Lyon, 69365

    Denis PERE VERGE, Dr, dpereverge@ch-stjoseph-stluc-lyon.fr; fannydenis@sfr.fr

    Recruiting

  • Hôpital Edouard Herriot

    Lyon, 69437

    Julien FORESTIER, Dr, julien.forestier@chu-lyon.fr

    Recruiting

  • Centre Radiologie

    Mâcon

    Isabelle POUCHARD, rthmacon@orange.fr; iporlem@orange.fr

    Isabelle POUCHARD

    Recruiting

  • Hôpital Européen Marseille

    Marseille, 13331

    Yves RINALDI, Dr, y.rinaldi@hopital-europeen.fr; yrinaldi@wanadoo.fr

    Recruiting

  • CHU La Timone

    Marseille, 13385

    Laétitia DAHAN, Pr, laetitia.dahan@ap-hm.fr

    Recruiting

  • Hopital Nord

    Marseille, 13915

    Mohamed GASMI, Dr, mohamed.gasmi@ap-hm.fr

    Recruiting

  • CH de Meaux

    Meaux, 77100

    Christophe LOCHER, Dr, c-locher@ch-meaux.fr

    Recruiting

  • Hôpital Layne

    Mont-de-Marsan, 40024

    Jérôme DAUBA, Dr, jerome.dauba@ch-mt-marsan.fr

    Recruiting

  • Centre Hospitalier

    Montélimar, 26216

    Agnès PELAQUIER, Dr, agnes.pelaquier@ch-montelimar.fr; agnes.pelaquier@free.fr

    Recruiting

  • Hôpital Monod

    Montivilliers, 76290

    Charline MARRE, Dr, charline.marre@ch-havre.fr; charlinemarre@gmail.com

    Recruiting

  • Centre Hospitalier

    Morlaix, 29672

    Marc FEREC, Dr, mferec@ch-morlaix.fr; marc_ferec@hotmail.com

    Recruiting

  • Centre Azuréen de Cancérologie

    Mougins, 06250

    Benjamin HOCH, Dr, dr.bhoch@gmail.com

    Recruiting

  • Hôpital Privé du Confluent SAS

    Nantes, 44277

    Hélène CASTANIE, Dr, helene.castanie@groupeconfluent.fr

    Recruiting

  • Hôpital Américain de Paris

    Neuilly-sur-Seine, 92200

    Lionel VEDRINE, Pr, lionelvedrine@orange.fr

    Recruiting

  • Hôpital Pierre Bérégovoy

    Nevers, 58033

    Abdelkader OUAZIR, Dr, abdelkader.ouazir@ch-nevers.fr

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Eric FRANCOIS, Dr, eric.francois@nice.unicancer.fr

    Recruiting

  • Centre Oncogard

    Nîmes, 30029

    Jacques CRETIN, Dr, cretinjacques@yahoo.fr

    Recruiting

  • CHU Carémeau

    Nîmes, 30029

    Valérie PHOUTTHASANG, Dr, Valivalo@hotmail.com

    Recruiting

  • Hôpital de la Source

    Orléans, 45067

    Jean-Paul LAGASSE, Dr, jean-paul.lagasse@chr-orleans.fr

    Recruiting

  • Hôpital Privé des Peupliers

    Paris, 75013

    Mustapha ZOUBIR, Dr, m.zoubir@gsante.fr

    Recruiting

  • Hôpital Saint Antoine

    Paris, 75571

    Daniel LOPEZ-TRABADA, Dr, daniel.lopez-trabada-ataz@aphp.fr

    Recruiting

  • HEGP

    Paris

    Julien TAIEB, julien.taieb@egp.aphp.fr; jtaieb75@gmail.com

    Julien TAIEB

    Recruiting

  • Hôpital Cochin

    Paris

    Romain CORIAT, romain.coriat@cch.aphp.fr

    Romain CORIAT

    Recruiting

  • Hôpital Saint Louis

    Paris

    Jean-Marc GORNET, jean-marc.gornet@sls.aphp.fr

    Jean-Marc GORNET

    Recruiting

  • Institut Montsouris

    Paris

    Christophe LOUVET, christophe.louvet@imm.fr

    Christophe LOUVET

    Recruiting

  • Pitié Salpêtière

    Paris

    Olivier DUBREUIL, olivier.dubreuil@aphp.fr

    Olivier DUBREUIL

    Recruiting

  • Centre Hospitalier

    Pau, 64046

    Juliette THAURY, Dr, juliette.thaury@ch-pau.fr; jthaury@yahoo.fr

    Recruiting

  • Polyclinique Francheville

    Périgueux, 24004

    Laurent CANY, Dr, l.cany@oncoradio24.com

    Recruiting

  • Hôpital Haut Leveque

    Pessac, 33604

    Eric TERREBONNE, Dr, eric.terrebonne@chu-bordeaux.fr

    Recruiting

  • CHU Lyon Sud

    Pierre-Bénite, 64495

    Claire FALANDRY, Dr, claire.falandry@chu-lyon.fr

    Recruiting

  • Centre CARIO - HCPA

    Plérin, 22190

    Pierre-Luc ETIENNE, Dr, pl.etienne@cario-sante.fr ; pl.etienne@wanadoo.fr

    Recruiting

  • Hôpital de la Milétrie

    Poitiers, 86021

    David TOUGERON, Pr, david.tougeron@chu-poitiers.fr

    Recruiting

  • CH Annecy Genevois

    Pringy, 74374

    Emmanuel MAILLARD, Dr, emaillard@ch-annecygenevois.fr

    Recruiting

  • CHU Robert Debré

    Reims, 51092

    Olivier BOUCHE, Pr, obouche@chu-reims.fr

    Recruiting

  • CHU de Pontchaillou

    Rennes, 35033

    Astrid LIEVRE, Pr, astrid.lievre@chu-rennes.fr

    Recruiting

  • Centre Eugène Marquis

    Rennes, 35042

    Astrid LIEVRE, Dr, astrid.lievre@chu-rennes.fr

    Recruiting

  • CH

    Rodez

    Laurent MOSSER, l.mosser@ch-rodez.fr

    Laurent MOSSER

    Recruiting

  • Hôpital Drome Nord

    Romans-sur-Isère, 26100

    Marie-Claude GOUTTEBEL, Dr, mc.gouttebel@hopitaux-drome-nord.fr

    Recruiting

  • CHU Charles Nicolle

    Rouen, 76031

    David SEFRIOUI, Dr, david.sefrioui@chu-rouen.fr

    Recruiting

  • Clinique Mathilde

    Rouen, 76175

    Sakher ALADEN, Dr

    Recruiting

  • Institut Curie

    Saint-Cloud, 92210

    Amani ASNACIOS-LECERF, Dr, amaniasnacios@yahoo.fr; amani.asnacioslecerf@curie.fr

    Recruiting

  • Hôpital Privé Saint Grégoire

    Saint-Grégoire, 35768

    Anne MERCIER BLAS, Dr, amercierblas@vivalto-sante.com

    Recruiting

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

    Sandrine HIRET, Dr, Sandrine.hiret@ico.unicancer.fr

    Recruiting

  • Polyclinique Côte Basque Sud

    Saint-Jean-de-Luz, 64500

    Etienne MAURIAC, Dr, etiennemauriac@gmail.com

    Recruiting

  • Hôpital d'Instruction des Armées Begin

    Saint-Mandé, 94163

    Serge CREMADES, Pr, cremades.sa@club-internet.fr

    Recruiting

  • CH Région Saint Omer

    Saint-Omer, 62505

    Claire CAPELLE, Dr, c.capelle@ch-boulogne.fr; claire.capelle@gmx.fr

    Recruiting

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

    Jean-Marc PHELIP, Pr, j.marc.phelip@chu-st-etienne.fr

    Recruiting

  • Polyclinique Saint Claude

    Saint-Quentin, 02100

    Pierre VANELSLANDER, Dr, vanelspi@gmail.com

    Recruiting

  • CH

    Saint-Quentin

    Innocenti DADAMESSI, I.dadamessi@ch-stquentin.fr;dadamessi@gmail.com

    Innocenti DADAMESSI

    Recruiting

  • CH Saintonge

    Saintes, 17108

    Florence BORDE-MOUGENOT, Dr, 3C@ch-saintonge.fr; f.borde@ch-saintonge.fr

    Recruiting

  • CH Morlevat

    Semur-en-Auxois, 21140

    Arnaud PATENOTTE, Dr, arnaud.patenotte@ch-semur-en-auxois.fr

    Recruiting

  • CH

    Senlis, 60309

    Elisabeth CAROLA, Dr, elisabeth.carola@ghpso.fr

    Recruiting

  • Centre Hospitalier

    Sens, 89108

    Hélène COSME GASSMANN, Dr, hcosme@ch-sens.fr

    Recruiting

  • Centre Hospitalier de Saint-Malo

    St-Malo, 35403

    Romain DESGRIPPES, Dr, r.desgrippes@ch-stmalo.fr

    Recruiting

  • Clinique Sainte Anne

    Strasbourg, 67000

    Louis-Marie DOURTHE, Dr, lm.dourthe@solcrr.org

    Recruiting

  • Centre Paul Strauss

    Strasbourg, 67065

    Meher BEN ABDELGHANI, Dr, mbenabdelghani@strasbourg.unicancer.fr

    Recruiting

  • Hôpitaux du Leman

    Thonon-les-Bains, 74203

    Ahmed BEDJAOUI, Dr, a-bedjaoui@ch-hopitauxduleman.fr

    Recruiting

  • Hôpital Sainte Musse

    Toulon, 83000

    Frédéric VIRET, Dr, frederic.viret@ch-toulon.fr

    Recruiting

  • Hôpital Sainte Musse

    Toulon, 83000

    Camille SIBERTIN-BLANC, Dr, camille.sibertin-blanc@ch-toulon.fr

    Recruiting

  • Clinique Saint Jean du Languedoc

    Toulouse, 31077

    Etienne Suc, Dr, esucsjl@club-internet.fr

    Recruiting

  • Hôpitaux Trousseau

    Tours, 37044

    Thierry LECOMTE, Pr, thierry.lecomte@med.univ-tours.fr

    Recruiting

  • Centre Hospitalier

    Valenciennes, 59322

    Isabelle BONNET, Dr, bonnet-i@ch-valenciennes.fr

    Recruiting

  • CHU de Nancy-Bradois

    Vandœuvre-lès-Nancy, 54511

    Anthony LOPEZ, Dr, anthony-lopez@hotmail.fr; a.lopez@chru-nancy.fr

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Marie-Christine KAMINSKY, Dr, mc.kaminsky@nancy.unicancer.fr

    Recruiting

  • Paul Brousse

    Villejuif

    Anne THIROT-BIDAULT, anne.bidault@bct.aphp.fr

    Anne THIROT-BIDAULT

    Recruiting

  • Centre Hospitalier

    Villeneuve-Saint-Georges, 94195

    Linda BOUAITA, Dr, lindabouaita@yahoo.fr

    Recruiting

Other trials in France

About this study

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

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.

Read more

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.

Read the 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.

Being tested
LV5FU2 or capectitabine, FOLFOX4 or XELOX, Observation, LV5FU2 or capecitabine
Keywords
Adjuvant chemotherapy in colonic adenocarcinoma in elderly
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LV5FU2 or capectitabineDrug

  • FOLFOX4 or XELOXDrug

  • ObservationOther

  • LV5FU2 or capecitabineDrug

Study groups in NCT02355379
Study groupRoleWhat they receive
GROUP1 -ARM AExperimentalLV5FU2 or capecitabine
Receives: Drug: LV5FU2 or capectitabine
GROUP1-ARMBExperimentalFOLFOX4 or XELOX
Receives: Drug: FOLFOX4 or XELOX
GROUP2- ARM CExperimentalObservation
Receives: Other: Observation
GROUP2-ARM DExperimentalLV5FU2 or capecitabine
Receives: Drug: LV5FU2 or capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The 3-year disease-free survival

    Measured: 3 years after last patient in

Secondary outcomes (2)

  1. Overal survival

    Measured: 5 years after last patient in

  2. Observed toxicities, graded according to NCI-CTC v4

    Measured: 3 years after last patient in

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2024 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
774 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02355379
Sponsor's protocol ID
PRODIGE34-ADAGE
Acronym
ADAGE
Status last verified
Jul 2024
First submitted
26 Jan 2015
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Aparicio T, Francois E, Cristol-Dalstein L, Carola E, Maillard E, Paillaud E, Retornaz F, Faroux R, Andre T, Bedenne L, Seitz JF. PRODIGE 34-FFCD 1402-ADAGE: Adjuvant chemotherapy in elderly patients with resected stage III colon cancer: A randomized phase 3 trial. Dig Liver Dis. 2016 Feb;48(2):206-7. doi: 10.1016/j.dld.2015.11.023. Epub 2015 Dec 2. No abstract available.

    PubMed 26748426

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LV5FU2 or capectitabine, FOLFOX4 or XELOX and Observation in people with Colonic Adenocarcinoma, run by Federation Francophone de Cancerologie Digestive at 140 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martina Schneider (+33 3 80 39 34 83, martina.schneider@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The 3-year disease-free survival (time frame: 3 years after last patient in). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02355379, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in