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

August 16, 2023 updated by: Federation Francophone de Cancerologie Digestive

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

774

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The 3-year disease-free survival
Time Frame: 3 years after last patient in
3 years after last patient in

Secondary Outcome Measures

Outcome Measure
Time Frame
Overal survival
Time Frame: 5 years after last patient in
5 years after last patient in
Observed toxicities, graded according to NCI-CTC v4
Time Frame: 3 years after last patient in
3 years after last patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Principal Investigator: Thomas Aparicio, Pr, FFCD member

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimated)

February 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRODIGE34-ADAGE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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