Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
NCT ID: NCT02575378
Last Updated: 2015-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
159 participants
INTERVENTIONAL
2015-09-30
2018-12-31
Brief Summary
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In this Prospective, open-label, randomised controlled trial, the investigators will recruit 159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and be randomised into two group, capecitabine metronomic chemotherapy only as control group and the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This treatment regimen will be continued until progression, death, or an unacceptable adverse event.
The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metronomic chemotherapy
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
Metronimic chemotherapy
Capecitabine 300mg/m2, twice a day, everyday
Metronimic chemotherapy plus Chinese Traditional Medicine
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
Chinese Traditional Medicine
Metronimic chemotherapy plus Chinese Traditional Medicine
Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine
Interventions
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Metronimic chemotherapy plus Chinese Traditional Medicine
Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine
Metronimic chemotherapy
Capecitabine 300mg/m2, twice a day, everyday
Eligibility Criteria
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Inclusion Criteria
2. patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR.
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Hao Li
associate chief physician, Department of Oncology
Other Identifiers
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ZHYY-ZYYZX-rjzl
Identifier Type: -
Identifier Source: org_study_id
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