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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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 70
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Research Institute of Clinical Oncology Nizhny Novgorod Regional Clinical Oncological Dispensary
RECRUITING
Nizhny Novgorod
Contact Information
Primary
Arina Datsyuk
doc70doc@yandex.ru
+79049209496
Backup
MIKHAIL OSIPOV
ocipovmixail@mail.ru
+79052075653
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 160
Treatments
Experimental: Fluoropyrimidines in mono-regimen
Capecitabine 2000mg/m2 per day, orally from day 1 to 14, 1 week break. Cycle of 21 days (start the next course on day 22).
Experimental: Combination chemotherapy based on platinum preparations
XELOX: Oxaliplatin 100-130mg/m2 w/v #1 on day 1 + Capecitabine 2000mg/m2 per day, orally from day 1 to 14, 1 week break.~Cycle of 21 days (start of the next course on day 22).
Related Therapeutic Areas
Sponsors
Leads: Nizhny Novgorod Regional Clinical Oncology Center

This content was sourced from clinicaltrials.gov