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RECRUITING
NCT06888843
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Capecitabine

Capecitabine 2000mg/m2 from day 1 to 14

DRUG

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