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

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ClinicalTrials.gov Identifier: NCT02355379
Recruitment Status : Recruiting
First Posted : February 4, 2015
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Colonic Adenocarcinoma Drug: LV5FU2 or capectitabine Drug: FOLFOX4 or XELOX Other: Observation Drug: LV5FU2 or capecitabine Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2015
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2025

Arm Intervention/treatment
Experimental: GROUP1 -ARM A
LV5FU2 or capecitabine
Drug: LV5FU2 or capectitabine
Experimental: GROUP1-ARMB
FOLFOX4 or XELOX
Drug: FOLFOX4 or XELOX
Experimental: GROUP2- ARM C
Observation
Other: Observation
Experimental: GROUP2-ARM D
LV5FU2 or capecitabine
Drug: LV5FU2 or capecitabine



Primary Outcome Measures :
  1. The 3-year disease-free survival [ Time Frame: 3 years after last patient in ]

Secondary Outcome Measures :
  1. Overal survival [ Time Frame: 5 years after last patient in ]
  2. safety: all observed toxicities, graded according to NCI-CTC v4 and the SAE [ Time Frame: 3 years after last patient in ]
  3. Determination of geriatric predictive factor [ Time Frame: 3 years after last patient in ]
    Exploratory analysis to search for geriatric prognostic factors for primary endpoint. Evolution of geriatric parametters during patients Follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355379


Contacts
Contact: Martina Schneider +33 3 80 39 34 83 martina.schneider@u-bourgogne.fr
Contact: Jaique Cario +33 3 80 39 34 86 jaique.cario_isat@u-bourgogne.fr

Locations
France
CROMG Recruiting
Agen, France
Contact: Adela CAUCHOIS    05 53 69 12 00      
Principal Investigator: Adela CAUCHOIS         
Sub-Investigator: Sévrine GUARNIERI         
Sub-Investigator: Xavier CARLES         
Sub-Investigator: Olivier BERNARD         
Clinique Claude Bernard Recruiting
Albi, France
Contact: Yann BERGE       berge@claude-bernard-albi.com   
Principal Investigator: Yann BERGE         
Sub-Investigator: Philippe HOUYAU         
Sub-Investigator: Marie-Hélène GASPARD         
Sub-Investigator: Amaury SYLVESTRE         
HOP Privé Recruiting
Annemasse, France
Contact: Oxana SHESTAEVA       o.shestaeva@ramsaygds.fr   
Principal Investigator: Oxana SHESTAEVA         
Hôpital Privé Bonnettes Recruiting
Arras, France
Contact: Bruno HUGUENIN       drbhuguenin@orange.fr   
Principal Investigator: Bruno HUGUENIN         
Sub-Investigator: Sophie BLANC         
CHU Avicenne Recruiting
BOBIGNY cedex, France, 93009
Contact: Thomas APARICIO, Pr    01 48 95 54 31    thomas.aparicio@avc.aphp.fr   
Contact: Mourad BENALLAOUA    01 48 95 54 31    thomas.aparicio@avc.aphp.fr   
Principal Investigator: Thomas APARICIO         
Sub-Investigator: Florence MARY         
CH Recruiting
Cahors, France
Contact: Nadia LEVASSEUR       nadia.levasseur@ch-cahors.fr   
Principal Investigator: Nadia LEVASSEUR         
CH Recruiting
Cherbourg en Cotentin, France
Contact: Laure KALUZINSKI       l.kaluzinski@ch-cherbourg.fr   
Principal Investigator: Laure KALUZINSKI         
Sub-Investigator: Arm ELWESHI         
Sub-Investigator: Jean-Nicolas PINHO         
CH Recruiting
Contamine sur Arve, France
Contact: Carol ALLIOT       calliot@ch-alpes-leman.fr   
Principal Investigator: Carol ALLIOT         
Clinique des Cèdres Recruiting
Cornebarrieu, France
Contact: Isabelle ROQUE       isa.roque@wanadoo.fr   
Principal Investigator: Isabelle ROQUE         
Sub-Investigator: Alain LEDIT         
CH Recruiting
Flers, France
Contact: Pierre-Emmanuel HENNERESSE       pierre-emmanuel.henneresse@ch-flers.fr ; netpeh@orange.fr   
Principal Investigator: Pierre-Emmanuel HENNERESSE         
Sub-Investigator: Laurent LION         
CH Recruiting
Gonesse, France
Principal Investigator: Sabri AHMED         
CH Recruiting
Le Coudray, France
Contact: Gabriela TOSSEN       gtossen@hotmail.com   
Principal Investigator: Gabriela TOSSEN         
Sub-Investigator: Michèle MANGOLD         
AP-HP Recruiting
Le Kremlin Bicetre, France
Contact: Anne THIROT-BIDAULT       anne.bidault@bct.aphp.fr   
Principal Investigator: Anne THIROT-BIDAULT         
Centre Radiologie Recruiting
Macon, France
Contact: Isabelle POUCHARD       rthmacon@orange.fr; iporlem@orange.fr   
Principal Investigator: Isabelle POUCHARD         
Sub-Investigator: Fabrice LORCHEL         
Sub-Investigator: Nicolas BARBET         
CH Recruiting
Macon, France
Contact: Fanny KAYAL       fannykayal@wanadoo.fr   
Principal Investigator: Fanny KAYAL         
Sub-Investigator: Chantal BERGER         
Sub-Investigator: Marie BELLECOSTE         
HEGP Recruiting
Paris, France
Contact: Julien TAIEB       julien.taieb@egp.aphp.fr; jtaieb75@gmail.com   
Principal Investigator: Julien TAIEB         
Sub-Investigator: Céline LEPERE         
Sub-Investigator: Bruno LANDI         
Sub-Investigator: Anne-Laure POINTET         
Sub-Investigator: Géraldine PERKINS         
Sub-Investigator: Aziz ZAANAN         
Sub-Investigator: Jean-Nicolas VAILLANT         
Sub-Investigator: Jeanne NETTER         
Sub-Investigator: Simon PERNOT         
Hôpital Cochin Recruiting
Paris, France
Contact: Romain CORIAT       romain.coriat@cch.aphp.fr   
Principal Investigator: Romain CORIAT         
Sub-Investigator: Marion DHOOGE         
Sub-Investigator: Johann DREANIC         
Sub-Investigator: Jean-Marie TIGAUD         
Sub-Investigator: Catherine BREZAULT         
Hôpital Saint Louis Recruiting
Paris, France
Contact: Jean-Marc GORNET       jean-marc.gornet@sls.aphp.fr   
Principal Investigator: Jean-Marc GORNET         
Institut Montsouris Recruiting
Paris, France
Contact: Christophe LOUVET       christophe.louvet@imm.fr   
Principal Investigator: Christophe LOUVET         
Sub-Investigator: Mostefa BENNANMOUN         
Sub-Investigator: Jean-Luc MOLITOR         
Pitié Salpêtière Recruiting
Paris, France
Contact: Olivier DUBREUIL       olivier.dubreuil@aphp.fr   
Principal Investigator: Olivier DUBREUIL         
Sub-Investigator: Jean-Baptiste BACHET         
Sub-Investigator: Solène DOAT         
CH Recruiting
Rodez, France
Contact: Laurent MOSSER       l.mosser@ch-rodez.fr   
Principal Investigator: Laurent MOSSER         
CH Recruiting
Saint Quentin, France
Contact: Innocenti DADAMESSI       I.dadamessi@ch-stquentin.fr;dadamessi@gmail.com   
Principal Investigator: Innocenti DADAMESSI         
Paul Brousse Recruiting
Villejuif, France
Contact: Anne THIROT-BIDAULT       anne.bidault@bct.aphp.fr   
Principal Investigator: Anne THIROT-BIDAULT         
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Principal Investigator: Thomas Aparicio, Pr FFCD member

Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT02355379     History of Changes
Other Study ID Numbers: PRODIGE34-ADAGE
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Federation Francophone de Cancerologie Digestive:
Adjuvant chemotherapy in colonic adenocarcinoma in elderly

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs