Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over
- Conditions
- Colonic Adenocarcinoma
- Interventions
- Registration Number
- NCT02355379
- Lead Sponsor
- Federation Francophone de Cancerologie Digestive
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 774
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GROUP2-ARM D LV5FU2 or capecitabine LV5FU2 or capecitabine GROUP1 -ARM A LV5FU2 or capectitabine LV5FU2 or capecitabine GROUP1-ARMB FOLFOX4 or XELOX FOLFOX4 or XELOX GROUP2- ARM C Observation Observation
- Primary Outcome Measures
Name Time Method The 3-year disease-free survival 3 years after last patient in
- Secondary Outcome Measures
Name Time Method Overal survival 5 years after last patient in Observed toxicities, graded according to NCI-CTC v4 3 years after last patient in
Trial Locations
- Locations (119)
Hopital Nord
🇫🇷Marseille CEDEX 20, France
CH d'Abbeville
🇫🇷Abbeville CEDEX, France
Centre hospitalier d'Albi
🇫🇷Albi, France
CROMG
🇫🇷Agen, France
Clinique Claude Bernard
🇫🇷Albi, France
Centre Oncogard
🇫🇷Nîmes CEDEX 9, France
Hôpital Sud
🇫🇷Amiens CEDEX 1, France
CH Victor Dupouy
🇫🇷Argenteuil, France
HOP Privé
🇫🇷Annemasse, France
Hôpital Les Bonnettes
🇫🇷Arras CEDEX, France
Hôpital Privé Bonnettes
🇫🇷Arras, France
Centre Hospitalier Ardèche Méridionale
🇫🇷Aubenas CEDEX, France
CH D'Auxerre
🇫🇷Auxerre, France
CH Côte Basque
🇫🇷Bayonne CEDEX, France
Hôpital de Bayeux
🇫🇷Bayeux CEDEX, France
Centre d'Oncologie et de Radiothérapie du Pays-Basque
🇫🇷Bayonne, France
CH de Beauvais
🇫🇷Beauvais, France
CH de Blois
🇫🇷Blois, France
CHU Avicenne
🇫🇷BOBIGNY cedex, France
Polyclinique Bordeaux Nord
🇫🇷Bordeaux CEDEX, France
Hôpital Duchenne
🇫🇷Boulogne-sur-Mer, France
Hôpital Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
Clinique Pasteur Saint Esprit
🇫🇷Brest, France
CHU Côte de Nacre
🇫🇷Caen, France
CH
🇫🇷Senlis CEDEX, France
Hôpital Privé Sainte Marie
🇫🇷Chalon-sur-Saône, France
Centre Hospitalier Public du Cotentin
🇫🇷Cherbourg, France
Centre Hospitalier Métropole Savoie
🇫🇷Chambery CEDEX, France
CHU Estaing
🇫🇷Clermont-Ferrand, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonnes, France
Centre Hospitalier
🇫🇷Villeneuve-Saint-Georges, France
Service de médecine
🇫🇷Digne-les-Bains, France
Hôpital François Mitterand
🇫🇷Dijon CEDEX, France
Institut de Cancérologie de Bourgogne - GRRECC
🇫🇷Dijon, France
Centre Goerges François Leclerc
🇫🇷Dijon, France
CHI Elbeuf-Louviers-Val de Reuil
🇫🇷Elbeuf, France
CH Marne La Vallée-Jossigny
🇫🇷Jossigny, France
CHI de Fréjus Saint-Raphaël
🇫🇷Fréjus, France
CH du Mans
🇫🇷Le Mans CEDEX 9, France
Groupe Hospitalier de la Rochelle Ré-Aunis
🇫🇷La Rochelle, France
CHU Dupuytren
🇫🇷Limoges, France
Clinique François Chénieux
🇫🇷Limoges, France
CHRU Hôpital Claude Huriez 4eme EST
🇫🇷Lille, France
Clinique de la Sauvegarde
🇫🇷Lyon CEDEX 09, France
Clinique Mutualiste Eugène André
🇫🇷Lyon, France
Hôpital Privé Jean Mermoz
🇫🇷Lyon, France
CH ST Joseph-ST Luc
🇫🇷Lyon, France
Centre Radiologie
🇫🇷Macon, France
CHU La Timone
🇫🇷Marseille CEDEX 5, France
Hôpital Monod
🇫🇷Montivilliers, France
CHU Carémeau
🇫🇷Nîmes, France
HEGP
🇫🇷Paris, France
Hôpital Cochin
🇫🇷Paris, France
Hôpital Saint Louis
🇫🇷Paris, France
Pitié Salpêtière
🇫🇷Paris, France
Hôpital Haut Leveque
🇫🇷Pessac CEDEX, France
Centre CARIO - HCPA
🇫🇷Plérin, France
Hôpital de la Milétrie
🇫🇷Poitiers, France
CH Annecy Genevois
🇫🇷Pringy, France
Polyclinique Francheville
🇫🇷Périgueux, France
CHU Robert Debré
🇫🇷Reims CEDEX, France
CHU Charles Nicolle
🇫🇷Rouen CEDEX 01, France
CHU de Pontchaillou
🇫🇷Rennes CEDEX 9, France
Hôpital Drome Nord
🇫🇷Romans-sur-Isère, France
Centre Eugène Marquis
🇫🇷Rennes CEDEX, France
ICO - Site René Gauducheau
🇫🇷Saint Herblain, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷Saint Priest en Jarez, France
Hôpital Privé Saint Grégoire
🇫🇷Saint Gregoire, France
Centre Hospitalier de Saint-Malo
🇫🇷Saint-Malo, France
Polyclinique Saint Claude
🇫🇷Saint-Quentin, France
CH Région Saint Omer
🇫🇷St Omer, France
CH Morlevat
🇫🇷Semur-en-Auxois, France
Hôpital d'Instruction des Armées Begin
🇫🇷Saint-Mandé, France
Clinique Sainte Anne
🇫🇷Strasbourg, France
Hôpitaux du Leman
🇫🇷Thonon-les-Bains, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Hôpital Sainte Musse
🇫🇷Toulon, France
CHU de Nancy-Bradois
🇫🇷Vandoeuvre les nancy, France
Clinique Saint Jean du Languedoc
🇫🇷Toulouse, France
Hôpitaux Trousseau
🇫🇷Tours CEDEX 9, France
Paul Brousse
🇫🇷Villejuif, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre les nancy, France
ICO Site Paul Papin
🇫🇷Angers CEDEX 2, France
CHU d'Angers
🇫🇷Angers CEDEX 9, France
Institut Sainte Catherine
🇫🇷Avignon CEDEX, France
CH William Morey
🇫🇷Chalon-sur-Saône, France
Infirmerie Protestante de Lyon
🇫🇷Caluire-et-Cuire, France
Centre Hospitalier Général
🇫🇷Châlons-en-Champagne, France
Clinique des Cèdres
🇫🇷Cornebarrieu, France
Centre Hospitalier de Dax
🇫🇷Dax CEDEX, France
Centre médical des Forcilles
🇫🇷Férolles-Attilly, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France
Centre Oscar Lambret
🇫🇷Lille, France
CHBS - Hôpital du Scorff
🇫🇷Lorient CEDEX, France
CHU de Lyon - Croix Rousse
🇫🇷Lyon, France
Hôpital Européen Marseille
🇫🇷Marseille CEDEX 03, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
CH de Meaux
🇫🇷Meaux, France
Hôpital Privé du Confluent SAS
🇫🇷Nantes, France
Hôpital Pierre Bérégovoy
🇫🇷Nevers CEDEX, France
Centre Antoine Lacassagne
🇫🇷Nice CEDEX 2, France
Hôpital Saint Antoine
🇫🇷Paris, France
Hôpital de la Source
🇫🇷Orléans CEDEX 2, France
Hôpital Privé des Peupliers
🇫🇷Paris, France
Institut Montsouris
🇫🇷Paris, France
CHU Lyon Sud
🇫🇷Pierre-Bénite, France
Institut Curie
🇫🇷Saint-Cloud, France
Clinique Mathilde
🇫🇷Rouen CEDEX, France
CH Saintonge
🇫🇷Saintes, France
Centre Azuréen de Cancérologie
🇫🇷Mougins, France
Centre hospitalier du Pays d'Aix
🇫🇷Aix-en-Provence, France
CH de Béziers
🇫🇷Béziers, France
CHU de Grenoble - Hôpital A. Michallon
🇫🇷Grenoble CEDEX, France
Hôpital Henri Duffaut
🇫🇷Avignon, France
Hopitaux Civils de Colmar
🇫🇷Colmar, France
Hôpital Layne
🇫🇷Mont-de-Marsan, France
Hôpital Américain de Paris
🇫🇷Neuilly-sur-Seine, France
Polyclinique Côte Basque Sud
🇫🇷Saint-Jean-de-Luz, France
CHU de Fort de France
🇫🇷Fort De France, Guadeloupe, France