Status:
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.
Lead Sponsor:
Nizhny Novgorod Regional Clinical Oncology Center
Conditions:
Colorectal Cancer
Eligibility:
All Genders
70-90 years
Phase:
PHASE2
Brief 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 fluo...
Detailed Description
The study is a single-center, open-label, randomized Phase II study. The study will be divided into a screening phase (4 weeks prior to inclusion in the study), a treatment phase (up to 6 months) and ...
Eligibility Criteria
Inclusion
- 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;
- Adequate liver, kidney and bone marrow function;
- Absence of severe uncontrolled concomitant chronic diseases and acute illnesses.
Exclusion
- Having previously received any systemic therapy for CRC;
- Time after surgical treatment of more than 12 weeks;
- Stage I-II and IV disease;
- Confirmed dihydropyrimidine dehydrogenase deficiency in blood by PCR (alteration of alleles c.\[190511G \> A\], c.\[1679T \>G\],\[2846A \> T\], \[1129-5923C \>G\], \[c.1236 G\>A(HapB3)\]);
- Severe uncontrolled comorbid chronic diseases or acute illnesses;
- Presence of a second malignancy (except for previously cured malignancies);
- Any condition that, in the opinion of the physician, would interfere with the study procedures.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06888843
Start Date
February 1 2025
End Date
February 1 2028
Last Update
March 27 2025
Active Locations (1)
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1
Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary"
Nizhny Novgorod, Russia, 603126