Actively Recruiting
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.
Led by Nizhny Novgorod Regional Clinical Oncology Center · Updated on 2025-03-27
160
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years and older
- Provided informed consent to participate
- Diagnosis of colorectal cancer confirmed by pathology
- Stage III colorectal cancer
- Underwent radical surgery for primary colorectal tumor
- ECOG performance status of 0 or 1
- Life expectancy greater than 6 months
- No prior systemic drug treatment for colorectal cancer
- Adequate liver, kidney, and bone marrow function
- No severe uncontrolled chronic diseases or acute illnesses
You will not qualify if you...
- Previous systemic therapy for colorectal cancer
- More than 12 weeks since surgical treatment
- Stage I, II, or IV colorectal cancer
- Confirmed dihydropyrimidine dehydrogenase deficiency by PCR
- Severe uncontrolled chronic diseases or acute illnesses
- Presence of a second malignancy except cured cancers
- Any condition interfering with study procedures as judged by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary"
Nizhny Novgorod, Russia, 603126
Actively Recruiting
Research Team
A
Arina Datsyuk
CONTACT
M
MIKHAIL OSIPOV
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here