Study to Evaluate the Use of Capecitabine in Monotherapy and in Combination With Oxaliplatin in E… (NCT06888843) | Clinical Trial Compass
RecruitingPhase 2
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.
Russia160 participantsStarted 2025-02-01
Plain-language 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).
Who can participate
Age range70 Years – 90 Years
SexALL
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Inclusion criteria
✓. Age 70 years and older;
✓. Obtaining informed consent to participate in the study;
✓. Morphologically confirmed diagnosis of colorectal cancer;
✓. Stage III colorectal cancer;
✓. Underwent radical surgical intervention for primary colorectal tumor;
✓. ECOG score of 0 - I;
✓. Life expectancy of more than 6 months;
✓. No history of systemic drug therapy for CRC;
Exclusion criteria
✕. Having previously received any systemic therapy for CRC;
✕. Time after surgical treatment of more than 12 weeks;
✕. Stage I-II and IV disease;
What they're measuring
1
The disease free survival
Timeframe: 3 years
Trial details
NCT IDNCT06888843
SponsorNizhny Novgorod Regional Clinical Oncology Center