Status:

RECRUITING

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

Lead Sponsor:

Federation Francophone de Cancerologie Digestive

Conditions:

Colonic Adenocarcinoma

Eligibility:

All Genders

75+ years

Phase:

PHASE3

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 chemoth...

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 chemoth...

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.

Key Trial Info

Start Date :

January 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2025

Estimated Enrollment :

774 Patients enrolled

Trial Details

Trial ID

NCT02355379

Start Date

January 1 2015

End Date

August 1 2025

Last Update

July 8 2024

Active Locations (140)

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Page 1 of 35 (140 locations)

1

CHU de Fort de France

Fort de France, Guadeloupe, France, 97261

2

CH d'Abbeville

Abbeville, France, 80142

3

CROMG

Agen, France

4

Centre hospitalier du Pays d'Aix

Aix-en-Provence, France, 13616

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