Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fluoropyrimidines in mono-regimen
- description
- 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).
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- Combination chemotherapy based on platinum preparations
- description
- 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).
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- The disease free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available