NCT06888843RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 6 Mar 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Nizhny Novgorod Regional Clinical Oncology Center
- Diseases
- Colorectal cancer
- NCT number
- NCT06888843
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 160
- From 1 Feb 2025 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having previously received any systemic therapy for CRC;
- Time after surgical treatment of more than 12 weeks;
- Presence of a second malignancy (except for previously cured malignancies);
Other illness
- Stage I-II and IV disease;
- Severe uncontrolled comorbid chronic diseases or acute illnesses;
- Any condition that, in the opinion of the physician, would interfere with the study procedures.
Other
- Confirmed dihydropyrimidine dehydrogenase deficiency in blood by PCR (alteration of alleles c.\[190511G \> A\], c.\[1679T \>G\],\[2846A \> T\], \[1129-5923C \>G\], \[c.1236 G\>A(HapB3)\]);
Who the study is looking for
- 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.
Age in the registry: 70 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary" Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.