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.
Recruiting
Phase 2
Interventional Study
Colorectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 70 – 90
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 160 (estimated)
- Sponsor
- Nizhny Novgorod Regional Clinical Oncology Center · Government
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About This Trial
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, …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 70 years and older;
2. Obtaining informed consent to participate in the study;
3. Morphologically confirmed diagnosis of colorectal cancer;
4. Stage III colorectal cancer;
5. Underwent radical surgical intervention for primary colorectal tumor;
6. ECOG score of 0 - I;
7. …
Contacts