drugset / Trial / NCT06888843

Study to Evaluate the Use of Capecitabine in Monotherapy and in Combination With Oxaliplatin in Elderly Patients as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer.

NCT06888843 ↗

Phase 2 Recruiting 160 enrolled Nizhny Novgorod Regional Clinical Oncology Center
RandomizedParallel-groupOpen-labelTreatment

Summary

All patients with locally advanced colorectal cancer after radical surgical intervention who have not previously received systemic antitumor treatment will be randomized into two groups receiving fluoropyrimidines in mono-regimen and in combination with oxaliplatin. Main objectives: * to compare the 3-year disease-free survival and 5-year overall survival rates in the two groups. * to identify, through a comprehensive geriatric assessment among elderly patients, the groups that benefit most from adjuvant chemotherapy. Patients will be treated until progression of the process is detected or the maximum effect of therapy is reached (the longest duration of treatment is 6 months).

Timeline

Start
2025-02-01
Primary completion
2028-02-01
Completion
2028-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 2000 mg/m2 Oral
Subject Oxaliplatin Small molecule 130 mg/m2 —

Indications