Maintenance Chemotherapy for Metastatic Colorectal Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- placebo
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Beijing Chao Yang Hospital
- Enrollment
- 80
- Primary Endpoint
- DDC:Duration of Disease Control
- Last Updated
- 12 years ago
Overview
Brief Summary
Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.
Detailed Description
Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.Therefore, our study is designed to investigate that colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.
Investigators
Dong Yan
Beijing Chao Yang Hospital
Beijing Chao Yang Hospital
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions \< 1.5 upper normal limit (UNL).
- •Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent
Exclusion Criteria
- •Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome
Arms & Interventions
Placebo
Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days
Intervention: placebo
Capecitabine
Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days
Intervention: Capecitabine
Outcomes
Primary Outcomes
DDC:Duration of Disease Control
Time Frame: 2 years
progression-free survival of first-line chemotherapy with second-line chemotherapy
Secondary Outcomes
- OS:Overall Survival(2 years)
- DCR:Disease Control Rate(2 years)