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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.
OBJECTIVES Primary evaluate the disease free survival rate of three years in patients with stage IIIC or resectable stage IV colorectal cancer treated with maintenance capecitabine.
Secondary
OUTLINE: This is a single arm, single-enter study. Patients are receiving therapies as below.
Patients undergo R0-R1 resection and receive adjuvant chemotherapy oxaliplatin with fluorouracil (5FU) and folinic acid(FOLFOX)or oxaliplatin with oxaliplatin with capecitabine(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.
Quality of life is assessed at completion of adjuvant treatment, at completion of maintenance chemotherapy , and at 1 year after maintenance chemotherapy.
After completion of adjuvant treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Eligibility Ages Eligible for Study: 18-80 Years old Genders Eligible for Study: Both Accepts Healthy Volunteers: No
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival rate(DFS) | 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 | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Over all survival,genetic patterns, quality of life, toxic effects, convenience |
|
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Inclusion Criteria:
Diagnosis of Adenocarcinoma of the colon or rectum
Age:18-80 years old
Received curative resection when diagnosed as colorectal cancer, postoperative stage: IIIC OR IV(R0 resected)
Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months 5.15 days prior recruit, meet the following criteria:
6.The ECOG scores: 0~1
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanhong Deng, MD | Contact | 008613925106525 | 13925106525@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanhong Deng, MD | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37814832 | Derived | Ling 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| 5 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |