Clinical trial · Interventional
Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer
Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV
- 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)
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy with capecitabine is still unknown. PURPOSE: This single arm study is exploring surgical resection and adjuvant chemotherapy followed by maintenance therapy with capecitabine to see the efficacy and safety, then to investigate the effect of maintenance therapy for stage IIIC or R0 resected stage IV colorectal cancer.
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine
- description
- Patients undergo R0-R1 resection and receive adjuvant chemotherapy FOLFOX or Capox for no less than 4 months. Radiotherapy may be applied for patients with rectal cancer if clinicians suspect that is necessary. Then patients receive oral capecitabine for 12 months maintenance.
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Disease-free Survival rate(DFS)
- timeFrame
- 36 months
- description
- From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes (1)
- measure
- Over all survival,genetic patterns, quality of life, toxic effects, convenience
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of Adenocarcinoma of the colon or rectum 2. Age:18-80 years old 3. Received curative resection when diagnosed as colorectal cancer, postoperative stage: IIIC OR IV(R0 resected) 4. Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months 5.15 days prior recruit, meet the following criteria: * Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hepatic * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * Aspartate transaminase ≤ 2.5 times ULN * Alanine transaminase ≤ 2.5 times ULN * No hepatic disease that would preclude study treatment or follow-up * No uncontrolled coagulopathy * Renal * Creatinine clearance \> 50 mL/min * No renal disease that would preclude study treatment or follow-up 6.The ECOG scores: 0~1 Exclusion Criteria: 1. Other colorectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma) 2. Synchronous cancer of other site 3. Hypersensitivity to capecitabine 4. No More than 4 weeks since prior participation in any investigational drug study 5. Clear indication of involvement of the pelvic side walls by imaging With distant metastasis 6. History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception 7. Uncontrolled hypertension 8. Cardiovascular disease that would preclude study treatment or follow-up 9. Lack of upper gastrointestinal tract integrity or malabsorption syndrome,active upper gastrointestinal tract bleeding 10. Pregnant or nursing, Fertile patients do not use effective contraception 11. Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum 12. No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
References
Publications (1)
- DERIVEDLing J, Lin Z, Shi L, Lin Y, Liu X, Lin J, Li J, Zhang J, Hu H, Cai Y, Deng Y. Capecitabine maintenance therapy in metastatic colorectal cancer patients with no evidence of disease: CAMCO trial. Future Oncol. 2023 Sep;19(30):2045-2054. doi: 10.2217/fon-2023-0149. Epub 2023 Oct 10. PMID 37814832