Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over
NCT ID: NCT02355379
Last Updated: 2024-07-08
Study Results
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Basic Information
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RECRUITING
PHASE3
774 participants
INTERVENTIONAL
2015-01-31
2025-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GROUP1 -ARM A
LV5FU2 or capecitabine
LV5FU2 or capectitabine
GROUP1-ARMB
FOLFOX4 or XELOX
FOLFOX4 or XELOX
GROUP2- ARM C
Observation
Observation
GROUP2-ARM D
LV5FU2 or capecitabine
LV5FU2 or capecitabine
Interventions
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LV5FU2 or capectitabine
FOLFOX4 or XELOX
Observation
LV5FU2 or capecitabine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
75 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Thomas Aparicio, Pr
Role: PRINCIPAL_INVESTIGATOR
FFCD member
Locations
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CHU de Fort de France
Fort de France, Guadeloupe, France
CH d'Abbeville
Abbeville, , France
CROMG
Agen, , France
Centre hospitalier du Pays d'Aix
Aix-en-Provence, , France
Centre hospitalier d'Albi
Albi, , France
Clinique Claude Bernard
Albi, , France
Clinique Claude Bernard
Albi, , France
Centre Oncogard
Alès, , France
Hôpital Sud
Amiens, , France
ICO Site Paul Papin
Angers, , France
CHU d'Angers
Angers, , France
HOP Privé
Annemasse, , France
CH Victor Dupouy
Argenteuil, , France
Hôpital Les Bonnettes
Arras, , France
Hôpital Privé Bonnettes
Arras, , France
Centre Hospitalier Ardèche Méridionale
Aubenas, , France
CH D'Auxerre
Auxerre, , France
Hôpital Henri Duffaut
Avignon, , France
Institut Sainte Catherine
Avignon, , France
Hôpital de Bayeux
Bayeux, , France
Centre d'Oncologie et de Radiothérapie du Pays-Basque
Bayonne, , France
CH Côte Basque
Bayonne, , France
CH de Beauvais
Beauvais, , France
CH de Béziers
Béziers, , France
CH de Blois
Blois, , France
CHU Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord
Bordeaux, , France
Hôpital Duchenne
Boulogne-sur-Mer, , France
Hôpital Pierre Oudot
Bourgoin, , France
Clinique Pasteur Saint Esprit
Brest, , France
CHU Côte de Nacre
Caen, , France
CH
Cahors, , France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, , France
CH William Morey
Chalon-sur-Saône, , France
Hôpital Privé Sainte Marie
Chalon-sur-Saône, , France
Centre Hospitalier Métropole Savoie
Chambéry, , France
Centre Hospitalier Général
Châlons-en-Champagne, , France
Centre Hospitalier Public du Cotentin
Cherbourg, , France
CH
Cherbourg, , France
CHU Estaing
Clermont-Ferrand, , France
Hopitaux Civils de Colmar
Colmar, , France
Centre Hospitalier
Compiègne, , France
CH
Contamine-sur-Arve, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
Clinique des Cèdres
Cornebarrieu, , France
Clinique des Cèdres
Cornebarrieu, , France
Centre Hospitalier de Dax
Dax, , France
Service de médecine
Digne-les-Bains, , France
Institut de Cancérologie de Bourgogne - GRRECC
Dijon, , France
Centre Goerges François Leclerc
Dijon, , France
Hôpital François Mitterand
Dijon, , France
CHI Elbeuf-Louviers-Val de Reuil
Elbeuf, , France
Centre médical des Forcilles
Férolles-Attilly, , France
CH
Flers, , France
CHI de Fréjus Saint-Raphaël
Fréjus, , France
Centre Hospitalier
Gap, , France
Centre Hospitalier
Gonesse, , France
CH
Gonesse, , France
CHU de Grenoble - Hôpital A. Michallon
Grenoble, , France
CH Marne La Vallée-Jossigny
Jossigny, , France
CHD Vendée
La Roche-sur-Yon, , France
Groupe Hospitalier de la Rochelle Ré-Aunis
La Rochelle, , France
CH
Le Coudray, , France
CH du Mans
Le Mans, , France
Centre Oscar Lambret
Lille, , France
CHRU Hôpital Claude Huriez 4eme EST
Lille, , France
Clinique François Chénieux
Limoges, , France
CHU Dupuytren
Limoges, , France
CH
Longjumeau, , France
CHBS - Hôpital du Scorff
Lorient, , France
Clinique Mutualiste Eugène André
Lyon, , France
Hôpital Privé Jean Mermoz
Lyon, , France
Clinique de la Sauvegarde
Lyon, , France
CHU de Lyon - Croix Rousse
Lyon, , France
CH ST Joseph-ST Luc
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Hôpital Européen Marseille
Marseille, , France
CHU La Timone
Marseille, , France
Hopital Nord
Marseille, , France
Centre Radiologie
Mâcon, , France
CH de Meaux
Meaux, , France
Hôpital Layne
Mont-de-Marsan, , France
Centre Hospitalier
Montélimar, , France
Hôpital Monod
Montivilliers, , France
Centre Hospitalier
Morlaix, , France
Centre Azuréen de Cancérologie
Mougins, , France
Hôpital Privé du Confluent SAS
Nantes, , France
Hôpital Américain de Paris
Neuilly-sur-Seine, , France
Hôpital Pierre Bérégovoy
Nevers, , France
Centre Antoine Lacassagne
Nice, , France
Centre Oncogard
Nîmes, , France
CHU Carémeau
Nîmes, , France
Hôpital de la Source
Orléans, , France
Hôpital Privé des Peupliers
Paris, , France
Hôpital Saint Antoine
Paris, , France
HEGP
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Saint Louis
Paris, , France
Institut Montsouris
Paris, , France
Pitié Salpêtière
Paris, , France
Centre Hospitalier
Pau, , France
Hôpital Haut Leveque
Pessac, , France
Polyclinique Francheville
Périgueux, , France
CHU Lyon Sud
Pierre-Bénite, , France
Centre CARIO - HCPA
Plérin, , France
Hôpital de la Milétrie
Poitiers, , France
CH Annecy Genevois
Pringy, , France
CHU Robert Debré
Reims, , France
CHU de Pontchaillou
Rennes, , France
Centre Eugène Marquis
Rennes, , France
CH
Rodez, , France
Hôpital Drome Nord
Romans-sur-Isère, , France
CHU Charles Nicolle
Rouen, , France
Clinique Mathilde
Rouen, , France
Institut Curie
Saint-Cloud, , France
Hôpital Privé Saint Grégoire
Saint-Grégoire, , France
ICO - Site René Gauducheau
Saint-Herblain, , France
Polyclinique Côte Basque Sud
Saint-Jean-de-Luz, , France
Hôpital d'Instruction des Armées Begin
Saint-Mandé, , France
CH Région Saint Omer
Saint-Omer, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Polyclinique Saint Claude
Saint-Quentin, , France
CH
Saint-Quentin, , France
CH Saintonge
Saintes, , France
CH Morlevat
Semur-en-Auxois, , France
CH
Senlis, , France
Centre Hospitalier
Sens, , France
Centre Hospitalier de Saint-Malo
St-Malo, , France
Clinique Sainte Anne
Strasbourg, , France
Centre Paul Strauss
Strasbourg, , France
Hôpitaux du Leman
Thonon-les-Bains, , France
Hôpital Sainte Musse
Toulon, , France
Hôpital Sainte Musse
Toulon, , France
Clinique Saint Jean du Languedoc
Toulouse, , France
Hôpitaux Trousseau
Tours, , France
Centre Hospitalier
Valenciennes, , France
CHU de Nancy-Bradois
Vandœuvre-lès-Nancy, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Paul Brousse
Villejuif, , France
Centre Hospitalier
Villeneuve-Saint-Georges, , France
Countries
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Central Contacts
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Facility Contacts
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Adela CAUCHOIS
Role: primary
Sakher ALADEN, Dr
Role: primary
References
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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.
Other Identifiers
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PRODIGE34-ADAGE
Identifier Type: -
Identifier Source: org_study_id
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