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Evaluating chemotherapy after surgery for elderly patients with stage III colon cancer

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

Phase 3 Interventional Federation Francophone de Cancerologie Digestive · NCT02355379

This study tests different chemotherapy options for elderly patients over 70 who have had surgery for stage III colon cancer to see which one helps them stay cancer-free longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment774 (estimated)
Ages75 Years and up
SexAll
SponsorFederation Francophone de Cancerologie Digestive Academic / other
Drugs / interventionschemotherapy
Locations140 sites (Fort de France, Guadeloupe and 139 other locations)
Trial IDNCT02355379 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial aims to assess the effectiveness of adjuvant chemotherapy in elderly patients aged 70 and over who have undergone resection for stage III colonic adenocarcinoma. The study will compare the benefits of different chemotherapy regimens, including fluoropyrimidine-based treatments and oxaliplatin, to determine their impact on disease-free survival. Given the underutilization of chemotherapy in this age group, the trial seeks to provide insights into the potential benefits and risks of these treatments for unselected elderly patients. Participants will be monitored closely to evaluate their response to the chemotherapy regimens.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 70 and older who have undergone successful resection of stage III colonic adenocarcinoma and are able to receive chemotherapy.

Not a fit: Patients with other progressive diseases or those who have had prior chemotherapy for colon cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and survival rates for elderly patients with stage III colon cancer.

How similar studies have performed: While there is limited data on the effectiveness of chemotherapy in very elderly patients, previous studies have shown benefits in selected populations, making this approach both relevant and necessary.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Fort de France, Guadeloupe and 139 other locations

+90 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colonic AdenocarcinomaAdjuvant chemotherapy in colonic adenocarcinoma in elderly
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.