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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.

NCT06888843 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-03-27

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Capecitabine

Capecitabine 2000mg/m2 from day 1 to 14

DRUG

Oxaliplatin

Oxaliplatin 130mg/m2 on day 1, cycle of 21 days

Sponsors & Collaborators

  • Nizhny Novgorod Regional Clinical Oncology Center

    lead OTHER_GOV

Principal Investigators

  • Sergey Gamayunov, DMS · Study Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2028-02-01
Completion
2028-02-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06888843 on ClinicalTrials.gov