Clinical Trial

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.

Study acronym: AHTCRR-1
Recruiting Phase 2
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-14.
Trial Details
NCT Number NCT06888843
Lead Sponsor Nizhny Novgorod Regional Clinical Oncology Center
Conditions Colorectal Cancer
Enrollment 160 participants
Start Date 2025-02-01
Primary Completion 2028-02-01 (estimated)
Study Completion 2028-02-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-27