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ClinicalTrials.gov ID

NCT02355379

Lead Sponsor

Federation Francophone de Cancerologie DigestiveOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

774Estimated

Last Update Posted

Jul 8, 2024Actual

Start Date

Jan 2015

Primary Completion Date

Dec 2024Estimated

Completion Date

Aug 2025Estimated

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

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.

• Colonic Adenocarcinoma

• LV5FU2 or capectitabine
• FOLFOX4 or XELOX
• Observation
• LV5FU2 or capecitabine

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Federation Francophone de Cancerologie DigestiveOTHER

05 53 69 12 00

hautefeuille.vincent@chu-amiens.fr

o.shestaeva@ramsaygds.fr

nadia.levasseur@ch-cahors.fr

l.kaluzinski@ch-cherbourg.fr

calliot@ch-alpes-leman.fr

pierre-emmanuel.henneresse@ch-flers.fr ; netpeh@orange.fr

gtossen@hotmail.com

joel.ezenfis@ch-longjumeau.fr

julien.taieb@egp.aphp.fr; jtaieb75@gmail.com

romain.coriat@cch.aphp.fr

olivier.dubreuil@aphp.fr

l.mosser@ch-rodez.fr

I.dadamessi@ch-stquentin.fr;dadamessi@gmail.com

elisabeth.carola@ghpso.fr