Status:
UNKNOWN
Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 R...
Detailed Description
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 1. Eva...
Eligibility Criteria
Inclusion
- 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:
- 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
- The ECOG scores: 0～1
Exclusion
- Other colorectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
- Synchronous cancer of other site
- Hypersensitivity to capecitabine
- No More than 4 weeks since prior participation in any investigational drug study
- Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
- History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
- Uncontrolled hypertension
- Cardiovascular disease that would preclude study treatment or follow-up
- Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
- Pregnant or nursing, Fertile patients do not use effective contraception
- 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
- No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01880658
Start Date
June 1 2013
End Date
May 1 2019
Last Update
February 11 2014
Active Locations (1)
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1
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655