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

Who is this study for? Older adult patients with Stage III Colon Adenocarcinoma
Status: Recruiting
Location: See all (140) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH d'Abbeville
RECRUITING
Abbeville
CROMG
RECRUITING
Agen
Centre hospitalier du Pays d'Aix
RECRUITING
Aix-en-provence
Centre hospitalier d'Albi
RECRUITING
Albi
Clinique Claude Bernard
RECRUITING
Albi
Clinique Claude Bernard
RECRUITING
Albi
Centre Oncogard
RECRUITING
Alès
Hôpital Sud
RECRUITING
Amiens
CHU d'Angers
RECRUITING
Angers
ICO Site Paul Papin
RECRUITING
Angers
HOP Privé
RECRUITING
Annemasse
CH Victor Dupouy
RECRUITING
Argenteuil
Hôpital Les Bonnettes
RECRUITING
Arras
Hôpital Privé Bonnettes
RECRUITING
Arras
Centre Hospitalier Ardèche Méridionale
RECRUITING
Aubenas
CH D'Auxerre
RECRUITING
Auxerre
Hôpital Henri Duffaut
RECRUITING
Avignon
Institut Sainte Catherine
RECRUITING
Avignon
Hôpital de Bayeux
RECRUITING
Bayeux
Centre d'Oncologie et de Radiothérapie du Pays-Basque
RECRUITING
Bayonne
CH Côte Basque
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Bayonne
CH de Beauvais
RECRUITING
Beauvais
CH de Béziers
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Béziers
CH de Blois
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Blois
CHU Avicenne
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Bobigny
Polyclinique Bordeaux Nord
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Bordeaux
Hôpital Duchenne
RECRUITING
Boulogne-sur-mer
Hôpital Pierre Oudot
RECRUITING
Bourgoin
Clinique Pasteur Saint Esprit
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Brest
CHU Côte de Nacre
RECRUITING
Caen
CH
RECRUITING
Cahors
Infirmerie Protestante de Lyon
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Caluire-et-cuire
CH William Morey
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Chalon-sur-saône
Hôpital Privé Sainte Marie
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Chalon-sur-saône
Centre Hospitalier Général
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Châlons-en-champagne
Centre Hospitalier Métropole Savoie
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Chambéry
Centre Hospitalier Public du Cotentin
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Cherbourg
CH
RECRUITING
Cherbourg
CHU Estaing
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Clermont-ferrand
Hopitaux Civils de Colmar
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Colmar
Centre Hospitalier
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Compiègne
CH
RECRUITING
Contamine-sur-arve
Centre Hospitalier Sud Francilien
RECRUITING
Corbeil-essonnes
Clinique des Cèdres
RECRUITING
Cornebarrieu
Clinique des Cèdres
RECRUITING
Cornebarrieu
Centre Hospitalier de Dax
RECRUITING
Dax
Service de médecine
RECRUITING
Digne-les-bains
Centre Goerges François Leclerc
RECRUITING
Dijon
Hôpital François Mitterand
RECRUITING
Dijon
Institut de Cancérologie de Bourgogne - GRRECC
RECRUITING
Dijon
CHI Elbeuf-Louviers-Val de Reuil
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Elbeuf
Centre médical des Forcilles
RECRUITING
Férolles-attilly
CH
RECRUITING
Flers
CHU de Fort de France
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Fort De France
CHI de Fréjus Saint-Raphaël
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Fréjus
Centre Hospitalier
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Gap
Centre Hospitalier
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Gonesse
CH
RECRUITING
Gonesse
CHU de Grenoble - Hôpital A. Michallon
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Grenoble
CH Marne La Vallée-Jossigny
RECRUITING
Jossigny
CHD Vendée
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La Roche-sur-yon
Groupe Hospitalier de la Rochelle Ré-Aunis
RECRUITING
La Rochelle
CH
RECRUITING
Le Coudray
CH du Mans
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Le Mans
Centre Oscar Lambret
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Lille
CHRU Hôpital Claude Huriez 4eme EST
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Lille
CHU Dupuytren
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Limoges
Clinique François Chénieux
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Limoges
CH
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Longjumeau
CHBS - Hôpital du Scorff
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Lorient
CH ST Joseph-ST Luc
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Lyon
CHU de Lyon - Croix Rousse
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Lyon
Clinique de la Sauvegarde
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Lyon
Clinique Mutualiste Eugène André
RECRUITING
Lyon
Hôpital Edouard Herriot
RECRUITING
Lyon
Hôpital Privé Jean Mermoz
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Lyon
Centre Radiologie
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Mâcon
CHU La Timone
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Marseille
Hôpital Européen Marseille
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Marseille
Hopital Nord
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Marseille
CH de Meaux
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Meaux
Hôpital Layne
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Mont-de-marsan
Centre Hospitalier
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Montélimar
Hôpital Monod
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Montivilliers
Centre Hospitalier
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Morlaix
Centre Azuréen de Cancérologie
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Mougins
Hôpital Privé du Confluent SAS
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Nantes
Hôpital Américain de Paris
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Neuilly-sur-seine
Hôpital Pierre Bérégovoy
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Nevers
Centre Antoine Lacassagne
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Nice
Centre Oncogard
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Nîmes
CHU Carémeau
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Nîmes
Hôpital de la Source
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Orléans
HEGP
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Paris
Hôpital Cochin
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Paris
Hôpital Privé des Peupliers
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Paris
Hôpital Saint Antoine
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Paris
Hôpital Saint Louis
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Paris
Institut Montsouris
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Paris
Pitié Salpêtière
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Paris
Centre Hospitalier
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Pau
Polyclinique Francheville
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Périgueux
Hôpital Haut Leveque
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Pessac
CHU Lyon Sud
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Pierre-bénite
Centre CARIO - HCPA
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Plérin
Hôpital de la Milétrie
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Poitiers
CH Annecy Genevois
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Pringy
CHU Robert Debré
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Reims
Centre Eugène Marquis
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Rennes
CHU de Pontchaillou
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Rennes
CH
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Rodez
Hôpital Drome Nord
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Romans-sur-isère
CHU Charles Nicolle
RECRUITING
Rouen
Clinique Mathilde
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Rouen
Institut Curie
RECRUITING
Saint-cloud
Hôpital Privé Saint Grégoire
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Saint-grégoire
ICO - Site René Gauducheau
RECRUITING
Saint-herblain
Polyclinique Côte Basque Sud
RECRUITING
Saint-jean-de-luz
Hôpital d'Instruction des Armées Begin
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Saint-mandé
CH Région Saint Omer
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Saint-omer
Institut de Cancérologie Lucien Neuwirth
RECRUITING
Saint-priest-en-jarez
CH
RECRUITING
Saint-quentin
Polyclinique Saint Claude
RECRUITING
Saint-quentin
CH Saintonge
RECRUITING
Saintes
CH Morlevat
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Semur-en-auxois
CH
RECRUITING
Senlis
Centre Hospitalier
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Sens
Centre Hospitalier de Saint-Malo
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St-malo
Centre Paul Strauss
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Strasbourg
Clinique Sainte Anne
RECRUITING
Strasbourg
Hôpitaux du Leman
RECRUITING
Thonon-les-bains
Hôpital Sainte Musse
RECRUITING
Toulon
Hôpital Sainte Musse
RECRUITING
Toulon
Clinique Saint Jean du Languedoc
RECRUITING
Toulouse
Hôpitaux Trousseau
RECRUITING
Tours
Centre Hospitalier
RECRUITING
Valenciennes
CHU de Nancy-Bradois
RECRUITING
Vandœuvre-lès-nancy
Institut de Cancérologie de Lorraine
RECRUITING
Vandœuvre-lès-nancy
Paul Brousse
RECRUITING
Villejuif
Centre Hospitalier
RECRUITING
Villeneuve-saint-georges
Contact Information
Primary
Martina Schneider
martina.schneider@u-bourgogne.fr
+33 3 80 39 34 83
Backup
Jaique Cario
jaique.cario_isat@u-bourgogne.fr
+33 3 80 39 34 86
Time Frame
Start Date: 2015-01
Estimated Completion Date: 2025-08
Participants
Target number of participants: 774
Treatments
Experimental: GROUP1 -ARM A
LV5FU2 or capecitabine
Experimental: GROUP1-ARMB
FOLFOX4 or XELOX
Experimental: GROUP2- ARM C
Observation
Experimental: GROUP2-ARM D
LV5FU2 or capecitabine
Authors
Marie BELLECOSTE
Related Therapeutic Areas
Sponsors
Leads: Federation Francophone de Cancerologie Digestive

This content was sourced from clinicaltrials.gov

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