Evaluating Capecitabine Alone and with Oxaliplatin for Elderly Patients with 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.
This study tests if the cancer drug Capecitabine, alone or with Oxaliplatin, can help older patients with advanced colorectal cancer live longer and stay cancer-free after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 70 Years to 90 Years |
| Sex | All |
| Sponsor | Nizhny Novgorod Regional Clinical Oncology Center Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nizhny Novgorod) |
| Trial ID | NCT06888843 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Capecitabine, both as a standalone treatment and in combination with Oxaliplatin, for elderly patients diagnosed with locally advanced colorectal cancer following radical surgery. Patients aged 70 and older will be randomized into two groups to compare their 3-year disease-free survival and 5-year overall survival rates. The study includes a comprehensive geriatric assessment to identify which patients benefit most from the adjuvant chemotherapy. Treatment will continue until disease progression or maximum therapeutic effect is achieved, with a follow-up period extending up to 3 years post-treatment.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 70 years and older with stage III colorectal cancer who have undergone radical surgical intervention.
Not a fit: Patients who have previously received systemic therapy for colorectal cancer or those with severe uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and treatment outcomes for elderly patients with locally advanced colorectal cancer.
How similar studies have performed: Other studies have shown promising results with similar chemotherapy regimens in colorectal cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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. Life expectancy of more than 6 months; 8. No history of systemic drug therapy for CRC; 9. Adequate liver, kidney and bone marrow function; 10. Absence of severe uncontrolled concomitant chronic diseases and acute illnesses. Exclusion Criteria: 1. Having previously received any systemic therapy for CRC; 2. Time after surgical treatment of more than 12 weeks; 3. Stage I-II and IV disease; 4. Confirmed dihydropyrimidine dehydrogenase deficiency in blood by PCR (alteration of alleles c.\[190511G \> A\], c.\[1679T \>G\],\[2846A \> T\], \[1129-5923C \>G\], \[c.1236 G\>A(HapB3)\]); 5. Severe uncontrolled comorbid chronic diseases or acute illnesses; 6. Presence of a second malignancy (except for previously cured malignancies); 7. Any condition that, in the opinion of the physician, would interfere with the study procedures.
Where this trial is running
Nizhny Novgorod
- Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary" — Nizhny Novgorod, Russia (Recruiting)
Study contacts
- Study coordinator: Arina Datsyuk
- Email: doc70doc@yandex.ru
- Phone: +79049209496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.