Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

Study Overview
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Brief Summary
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Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Detailed Description
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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.

Official Title
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Maintenance Chemotherapy for Metastatic Colorectal Carcinoma

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo<br>Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days | Other: placebo<br>* 14 days<br>|
| Experimental: Capecitabine<br>Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days | Drug: Capecitabine<br>* 14days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DDC:Duration of Disease Control | progression-free survival of first-line chemotherapy with second-line chemotherapy | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS:Overall Survival | measured from the initiation of chemotherapy to the date of the last follow-up or death | 2 years | 
| DCR:Disease Control Rate | This is defined as the occurrence of either a confirmed complete (CR),a partial response(PR)or stable disease(SD) as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions. | 2 years |