Clinical Research Directory
Browse clinical research sites, groups, and studies.
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.
Sponsor: Nizhny Novgorod Regional Clinical Oncology Center
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).
Official title: A Single-center, Open-label, Randomized Phase II 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.
Key Details
Gender
All
Age Range
70 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-02-01
Completion Date
2028-02-01
Last Updated
2025-03-27
Healthy Volunteers
No
Conditions
Interventions
Capecitabine
Capecitabine 2000mg/m2 from day 1 to 14
Oxaliplatin
Oxaliplatin 130mg/m2 on day 1, cycle of 21 days
Locations (1)
Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary"
Nizhny Novgorod, Russia