Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker
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|ClinicalTrials.gov Identifier: NCT02043821|
Recruitment Status : Unknown
Verified January 2014 by Dong Yan, Beijing Chao Yang Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 23, 2014
Last Update Posted : January 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Capecitabine Other: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Maintenance Chemotherapy for Metastatic Colorectal Carcinoma|
|Estimated Primary Completion Date :||January 2016|
Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days
Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days
- DDC:Duration of Disease Control [ Time Frame: 2 years ]progression-free survival of first-line chemotherapy with second-line chemotherapy
- OS:Overall Survival [ Time Frame: 2 years ]measured from the initiation of chemotherapy to the date of the last follow-up or death
- DCR:Disease Control Rate [ Time Frame: 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.
- Safety [ Time Frame: 2 years ]Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043821
|Contact: Dong Yan, PhDemail@example.com|
|Study Director:||Guangyu An, PhD||Beijing Chao Yang Hospital|