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

  • STATUS
    Recruiting
  • End date
    Aug 24, 2025
  • participants needed
    774
  • sponsor
    Federation Francophone de Cancerologie Digestive
Updated on 24 January 2021
Investigator
Martina Schneider
Primary Contact
CHU Estaing (0.0 mi away) Contact
+202 other location
cancer
oxaliplatin
capecitabine
fluoropyrimidine
colon cancer
primary tumor
stage iii colon cancer

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.

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.

Details
Condition Adenocarcinoma of the Colon, Colonic Adenocarcinoma, adenocarcinoma of colon
Treatment Observation, LV5FU2 or capectitabine, FOLFOX4 or XELOX, LV5FU2 or capecitabine
Clinical Study IdentifierNCT02355379
SponsorFederation Francophone de Cancerologie Digestive
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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