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

What this Trial Is About

Colorectal cancer mostly affects elderly patients, with over half diagnosed at age 70 or older in France. This research evaluates the benefit of adjuvant chemotherapy after surgical removal of stage III colon cancer in elderly patients, focusing on whether fluoropyrimidine-based or oxaliplatin-based chemotherapy improves disease-free survival. The study addresses concerns about the effectiveness of chemotherapy in very elderly or unfit patients and includes an assessment of tumor biological factors common in the elderly. Participants are divided into two groups based on a doctors evaluation involving a geriatrician, with different randomization assignments. Treatments being studied include chemotherapy regimens with LV5FU2 or capecitabine and FOLFOX4 or XELOX, as well as observation. The chemotherapy is started within 12 weeks after surgery. The study compares these approaches to determine the best adjuvant chemotherapy strategy for elderly patients. During the study, participants undergo assessments including geriatric questionnaires and monitoring of toxicities. Researchers measure disease-free survival three years after the last patient joins, along with overall survival at five years. Safety is evaluated by observing side effects graded by standard criteria. The study excludes patients with less than four years expected survival and ensures medical follow-up is possible. Participation duration and detailed monitoring support evaluating chemotherapy benefits in this population.

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