Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

Not Applicable

• Conditions: Metastatic Colorectal Cancer
• Interventions: Other: placebo; Drug: Capecitabine

• Registration Number: NCT02043821
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days
Capecitabine	Capecitabine	Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days

Primary Outcome Measures

Name	Time	Method
DDC:Duration of Disease Control	2 years	progression-free survival of first-line chemotherapy with second-line chemotherapy

Secondary Outcome Measures

Name	Time	Method
OS:Overall Survival	2 years	measured from the initiation of chemotherapy to the date of the last follow-up or death
DCR:Disease Control Rate	2 years	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.