RecruitingPhase 2NCT06888843

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.

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.

Sponsor

Nizhny Novgorod Regional Clinical Oncology Center

Enrollment

160 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

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).

Eligibility

Min Age: 70 YearsMax Age: 90 Years

Inclusion Criteria10

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 Criteria7

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.