Informations générales (source: ClinicalTrials.gov)
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 (ADAGE)
Interventional
Phase 3
Federation Francophone de Cancerologie Digestive (Voir sur ClinicalTrials)
janvier 2015
août 2025
09 juillet 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:34 | Contacter | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Romain CORIAT | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Paul Brousse | Anne THIROT-BIDAULT | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Daniel LOPEZ-TRABADA, Dr | Contact (sur clinicalTrials) | |||
| CENTRE HOSPITALIER DE GONESSE | Contact (sur clinicalTrials) | ||||
| CENTRE HOSPITALIER SUD FRANCILIEN | Samy LOUAFI, Dr | Contact (sur clinicalTrials) | |||
| CENTRE IMAGERIE SCANNER DE FORCILLES | Hélène DALL OSTO, Dr | Contact (sur clinicalTrials) | |||
| CH VICTOR DUPOUY ARGENTEUIL | Arnaud BOUTAN-LAROZE, Dr | Contact (sur clinicalTrials) | |||
| CLINIQUE VILLENEUVE SAINT GEORGES | Linda BOUAITA, Dr | Contact (sur clinicalTrials) | |||
| GPE HOSP BROUSSAIS HEGP | Julien TAIEB | Contact (sur clinicalTrials) | |||
| HOPITAL PRIVE DES PEUPLIERS | Mustapha ZOUBIR, Dr | Contact (sur clinicalTrials) | |||
| HOPITAL SUISSE DE PARIS | Lionel VEDRINE, Pr | Contact (sur clinicalTrials) | |||
| IFSI DE L'HÔPITAL SAINT LOUIS | Jean-Marc GORNET | Contact (sur clinicalTrials) | |||
| INSTITUT MUTUALISTE MONTSOURIS | Christophe LOUVET | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice CEDEX 2 - France | Eric FRANCOIS, Dr | Contact (sur clinicalTrials) | |||
| Centre Azuréen de Cancérologie - 06250 - Mougins - France | Benjamin HOCH, Dr | Contact (sur clinicalTrials) | |||
| Centre CARIO - HCPA - 22190 - Plérin - France | Pierre-Luc ETIENNE, Dr | Contact (sur clinicalTrials) | |||
| Centre d'Oncologie et de Radiothérapie du Pays-Basque - 64100 - Bayonne - France | Stéphane REMY, Dr | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - 35042 - Rennes CEDEX - France | Astrid LIEVRE, Dr | Contact (sur clinicalTrials) | |||
| Centre Goerges François Leclerc - 21079 - Dijon - France | Leila BENGRINE LEFEVRE, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - 05007 - Gap - France | Olivier GUILLEM, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - 29672 - Morlaix CEDEX - France | Marc FEREC, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - 60321 - Compiègne CEDEX - France | Jean-Christophe DUCHMANN, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - 64046 - Pau CEDEX - France | Juliette THAURY, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - 89108 - Sens CEDEX - France | Hélène COSME GASSMANN, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Ardèche Méridionale - 07205 - Aubenas CEDEX - France | Brigitte VELAY, Dr | Contact (sur clinicalTrials) | |||
| Centre hospitalier d'Albi - 81000 - Albi - France | Nadia MUNSCH, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Dax - 40107 - Dax CEDEX - France | Laure GAUTIER FELIZOT, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Saint-Malo - 35403 - Saint-Malo - France | Romain DESGRIPPES, Dr | Contact (sur clinicalTrials) | |||
| Centre hospitalier du Pays d'Aix - 13616 - Aix-en-Provence - France | Sophie NAHON BRISSONNEAU, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Général - 51005 - Châlons-en-Champagne - France | Naceur ABDELLI, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Métropole Savoie - 73011 - Chambery CEDEX - France | Jocelyne PROVENCAL, Dr | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59037 - Lille - France | Farid EL HAJBI, Dr | Contact (sur clinicalTrials) | |||
| Centre Paul Strauss - 67065 - Strasbourg - France | Meher BEN ABDELGHANI, Dr | Contact (sur clinicalTrials) | |||
| Centre Radiologie - Macon - France | Isabelle POUCHARD | Contact (sur clinicalTrials) | |||
| CH - 60309 - Senlis CEDEX - France | Elisabeth CAROLA, Dr | Contact (sur clinicalTrials) | |||
| CH - Cahors - France | Nadia LEVASSEUR | Contact (sur clinicalTrials) | |||
| CH - Contamine sur Arve - France | Carol ALLIOT | Contact (sur clinicalTrials) | |||
| CH - Flers - France | Pierre-Emmanuel HENNERESSE | Contact (sur clinicalTrials) | |||
| CH Annecy Genevois - 74374 - Pringy - France | Emmanuel MAILLARD, Dr | Contact (sur clinicalTrials) | |||
| CH Côte Basque - 64109 - Bayonne CEDEX - France | Franck AUDEMAR, Dr | Contact (sur clinicalTrials) | |||
| CH d'Abbeville - 80142 - Abbeville CEDEX - France | Mathieu PAUWELS, Dr | Contact (sur clinicalTrials) | |||
| CH de Beauvais - 60021 - Beauvais - France | Fayçal HOCINE, Dr | Contact (sur clinicalTrials) | |||
| CH de Béziers - 34525 - Béziers - France | Mohamed RAMDANI, Dr | Contact (sur clinicalTrials) | |||
| CH de Blois - 41000 - Blois - France | Dany GARGOT, Dr | Contact (sur clinicalTrials) | |||
| CH Morlevat - 21140 - Semur-en-Auxois - France | Arnaud PATENOTTE, Dr | Contact (sur clinicalTrials) | |||
| CH Saintonge - 17108 - Saintes - France | Florence BORDE-MOUGENOT, Dr | Contact (sur clinicalTrials) | |||
| CH ST Joseph-ST Luc - 69365 - Lyon - France | Denis PERE VERGE, Dr | Contact (sur clinicalTrials) | |||
| CH William Morey - 71100 - Chalon-sur-Saône - France | Laurie RAMBACH, Dr | Contact (sur clinicalTrials) | |||
| CHBS - Hôpital du Scorff - 56322 - Lorient CEDEX - France | Joëlle EGRETEAU, Dr | Contact (sur clinicalTrials) | |||
| CHI Elbeuf-Louviers-Val de Reuil - 76503 - Elbeuf - France | Anne-Marie QUENIET, Dr | Contact (sur clinicalTrials) | |||
| CHRU Hôpital Claude Huriez 4eme EST - 59037 - Lille - France | Anthony TURPIN, Dr | Contact (sur clinicalTrials) | |||
| CHU Avicenne - 93009 - BOBIGNY cedex - France | Thomas APARICIO, Pr | Contact (sur clinicalTrials) | |||
| CHU Carémeau - 30029 - Nîmes - France | Valérie PHOUTTHASANG, Dr | Contact (sur clinicalTrials) | |||
| CHU Charles Nicolle - 76031 - Rouen CEDEX 01 - France | David SEFRIOUI, Dr | Contact (sur clinicalTrials) | |||
| CHU Côte de Nacre - 14033 - Caen - France | Karine BOUHIER LEPORRIER, Dr | Contact (sur clinicalTrials) | |||
| CHU d'Angers - 49933 - Angers CEDEX 9 - France | Nathalie BAIZE, Dr | Contact (sur clinicalTrials) | |||
| CHU de Fort de France - 97261 - Fort De France - Guadeloupe - France | Nathalie GROSSAT BERNADOU, Dr | Contact (sur clinicalTrials) | |||
| CHU de Lyon - Croix Rousse - 69317 - Lyon - France | Marielle GUILLET, Dr | Contact (sur clinicalTrials) | |||
| CHU Dupuytren - 87042 - Limoges - France | Valérie LE BRUN LY, Dr | Contact (sur clinicalTrials) | |||
| CHU Estaing - 63003 - Clermont-Ferrand - France | Caroline PETORIN, Dr | Contact (sur clinicalTrials) | |||
| CHU Lyon Sud - 64495 - Pierre-Bénite - France | Claire FALANDRY, Dr | Contact (sur clinicalTrials) | |||
| CHU Robert Debré - 51092 - Reims CEDEX - France | Olivier BOUCHE, Pr | Contact (sur clinicalTrials) | |||
| Clinique Claude Bernard - 81030 - Albi - France | Yann BERGE, Dr | Contact (sur clinicalTrials) | |||
| Clinique Claude Bernard - Albi - France | Yann BERGE | Contact (sur clinicalTrials) | |||
| Clinique de la Sauvegarde - 69009 - Lyon CEDEX 09 - France | Isabelle MOULLET, Dr | Contact (sur clinicalTrials) | |||
| Clinique François Chénieux - 87000 - Limoges - France | Jean MARTIN, Dr | Contact (sur clinicalTrials) | |||
| Clinique Mathilde - 76175 - Rouen CEDEX - France | Sakher ALADEN, Dr | Contact (sur clinicalTrials) | |||
| Clinique Pasteur Saint Esprit - 29200 - Brest - France | Véronique JESTIN LE TALLEC, Dr | Contact (sur clinicalTrials) | |||
| Clinique Saint Jean du Languedoc - 31077 - Toulouse - France | Etienne Suc, Dr | Contact (sur clinicalTrials) | |||
| Clinique Sainte Anne - 67000 - Strasbourg - France | Louis-Marie DOURTHE, Dr | Contact (sur clinicalTrials) | |||
| HOP Privé - Annemasse - France | Oxana SHESTAEVA | Contact (sur clinicalTrials) | |||
| Hôpital de la Source - 45067 - Orléans CEDEX 2 - France | Jean-Paul LAGASSE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital d'Instruction des Armées Begin - 94163 - Saint-Mandé - France | Serge CREMADES, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Drome Nord - 26100 - Romans-sur-Isère - France | Marie-Claude GOUTTEBEL, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Duchenne - 62321 - Boulogne-sur-Mer - France | Vincent BOURGEOIS, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Haut Leveque - 33604 - Pessac CEDEX - France | Eric TERREBONNE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Layne - 40024 - Mont-de-Marsan - France | Jérôme DAUBA, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Les Bonnettes - 62012 - Arras CEDEX - France | Bruno HUGUENIN, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Monod - 76290 - Montivilliers - France | Charline MARRE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Pierre Bérégovoy - 58033 - Nevers CEDEX - France | Abdelkader OUAZIR, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Pierre Oudot - 38300 - Bourgoin-Jallieu - France | Benoit AVISSE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Privé du Confluent SAS - 44277 - Nantes - France | Hélène CASTANIE, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Privé Jean Mermoz - 69008 - Lyon - France | Jérôme DESRAME, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Privé Saint Grégoire - 35768 - Saint Gregoire - France | Anne MERCIER BLAS, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Privé Sainte Marie - 71100 - Chalon-sur-Saône - France | Adrien MELIS, Dr | Contact (sur clinicalTrials) | |||
| Hopitaux Civils de Colmar - 68024 - Colmar - France | Gilles BREYSACHER, Dr | Contact (sur clinicalTrials) | |||
| Hôpitaux du Leman - 74203 - Thonon-les-Bains - France | Ahmed BEDJAOUI, Dr | Contact (sur clinicalTrials) | |||
| ICO - Site René Gauducheau - 44805 - Saint Herblain - France | Sandrine HIRET, Dr | Contact (sur clinicalTrials) | |||
| ICO Site Paul Papin - 49055 - Angers CEDEX 2 - France | Sandrine HIRET, Dr | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Bourgogne - GRRECC - 21000 - Dijon - France | Geneviève BOILLEAU-JOLIMOY, Dr | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - 54519 - Vandoeuvre les nancy - France | Marie-Christine KAMINSKY, Dr | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie Lucien Neuwirth - 42271 - Saint Priest en Jarez - France | Jean-Marc PHELIP, Pr | Contact (sur clinicalTrials) | |||
| Institut Sainte Catherine - 84918 - Avignon CEDEX - France | Laurent MINEUR, Dr | Contact (sur clinicalTrials) | |||
| Polyclinique Bordeaux Nord - 33077 - Bordeaux CEDEX - France | Cédric LECAILLE, Dr | Contact (sur clinicalTrials) | |||
| Polyclinique Côte Basque Sud - 64500 - Saint-Jean-de-Luz - France | Etienne MAURIAC, Dr | Contact (sur clinicalTrials) | |||
| Polyclinique Francheville - 24004 - Périgueux - France | Laurent CANY, Dr | Contact (sur clinicalTrials) | |||
| Polyclinique Saint Claude - 02100 - Saint-Quentin - France | Pierre VANELSLANDER, Dr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier - 26216 - Montélimar - France | Agnès PELAQUIER, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier - 59322 - Valenciennes - France | Isabelle BONNET, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Public du Cotentin - 50102 - Cherbourg - France | Laure KALUZINSKI, Dr | Contact (sur clinicalTrials) | |||
| Centre Oncogard - 30029 - Nîmes CEDEX 9 - France | Jacques CRETIN, Dr | Contact (sur clinicalTrials) | |||
| Centre Oncogard - 30103 - Alès - France | Jacques CRETIN, Dr | Contact (sur clinicalTrials) | |||
| CH - 91164 - Longjumeau - France | Joël EZENFIS, Dr | Contact (sur clinicalTrials) | |||
| CH - Cherbourg - France | Laure KALUZINSKI | Contact (sur clinicalTrials) | |||
| CH - Le Coudray - France | Gabriela TOSSEN | Contact (sur clinicalTrials) | |||
| CH - Rodez - France | Laurent MOSSER | Contact (sur clinicalTrials) | |||
| CH - Saint Quentin - France | Innocenti DADAMESSI | Contact (sur clinicalTrials) | |||
| CH D'Auxerre - 89000 - Auxerre - France | Anne-Laure VILLING, Dr | Contact (sur clinicalTrials) | |||
| CH de Meaux - 77100 - Meaux - France | Christophe LOCHER, Dr | Contact (sur clinicalTrials) | |||
| CH du Mans - 72037 - Le Mans CEDEX 9 - France | Oana COJOCARASU, Dr | Contact (sur clinicalTrials) | |||
| CH Marne La Vallée-Jossigny - 77600 - Jossigny - France | Christine LE FOLL, Dr | Contact (sur clinicalTrials) | |||
| CH Région Saint Omer - 62505 - St Omer - France | Claire CAPELLE, Dr | Contact (sur clinicalTrials) | |||
| CHD Vendée - 85925 - La Roche-sur-Yon - France | Roger FAROUX, Dr | Contact (sur clinicalTrials) | |||
| CHI de Fréjus Saint-Raphaël - 83600 - Fréjus - France | Bruno VALENZA, Dr | Contact (sur clinicalTrials) | |||
| CHU de Grenoble - Hôpital A. Michallon - 38043 - Grenoble CEDEX - France | Jean-Luc FAUCHERON, Pr | Contact (sur clinicalTrials) | |||
| CHU de Nancy-Bradois - 54511 - Vandoeuvre les nancy - France | Anthony LOPEZ, Dr | Contact (sur clinicalTrials) | |||
| CHU de Pontchaillou - 35033 - Rennes CEDEX 9 - France | Astrid LIEVRE, Pr | Contact (sur clinicalTrials) | |||
| CHU La Timone - 13385 - Marseille CEDEX 5 - France | Laétitia DAHAN, Pr | Contact (sur clinicalTrials) | |||
| Clinique des Cèdres - 31700 - Cornebarrieu - France | Isabelle ROQUE, Dr | Contact (sur clinicalTrials) | |||
| Clinique des Cèdres - Cornebarrieu - France | Isabelle ROQUE | Contact (sur clinicalTrials) | |||
| Clinique Mutualiste Eugène André - 69003 - Lyon - France | Cécile FOURNEL, Dr | Contact (sur clinicalTrials) | |||
| CROMG - Agen - France | Adela CAUCHOIS | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier de la Rochelle Ré-Aunis - 17019 - La Rochelle - France | Marie BRECHON, Dr | Contact (sur clinicalTrials) | |||
| Hôpital de Bayeux - 14401 - Bayeux CEDEX - France | Annie PEYTIER, Dr | Contact (sur clinicalTrials) | |||
| Hôpital de la Milétrie - 86021 - Poitiers - France | David TOUGERON, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot - 69437 - Lyon - France | Julien FORESTIER, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Européen Marseille - 13331 - Marseille CEDEX 03 - France | Yves RINALDI, Dr | Contact (sur clinicalTrials) | |||
| Hôpital François Mitterand - 21079 - Dijon CEDEX - France | Côme LEPAGE, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Henri Duffaut - 84902 - Avignon - France | Olivier BOULAT, Dr | Contact (sur clinicalTrials) | |||
| Hopital Nord - 13915 - Marseille CEDEX 20 - France | Mohamed GASMI, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Privé Bonnettes - Arras - France | Bruno HUGUENIN | Contact (sur clinicalTrials) | |||
| Hôpital Sainte Musse - 83000 - Toulon - France | Camille SIBERTIN-BLANC, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Sud - 80054 - Amiens CEDEX 1 - France | Vincent HAUTEFEUILLE, Dr | Contact (sur clinicalTrials) | |||
| Hôpitaux Trousseau - 37044 - Tours CEDEX 9 - France | Thierry LECOMTE, Pr | Contact (sur clinicalTrials) | |||
| Infirmerie Protestante de Lyon - 69300 - Caluire-et-Cuire - France | Johannes HARTWIG, Dr | Contact (sur clinicalTrials) | |||
| Pitié Salpêtière - Paris - France | Olivier DUBREUIL | Contact (sur clinicalTrials) | |||
| Service de médecine - 04000 - Digne-les-Bains - France | Gilbert BORDES, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.