Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metronimic chemotherapy plus Chinese Traditional Medicine
Metronimic chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, Maintenance Treatment, Chinese Traditional Medicine, Clinical Trial, efficacy, safety
Eligibility Criteria
Inclusion Criteria:
- unresectable metastatic colorectal cancer with pathological confirmation.
- patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR.
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Metronomic chemotherapy
Metronimic chemotherapy plus Chinese Traditional Medicine
Arm Description
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday. Chinese Traditional Medicine
Outcomes
Primary Outcome Measures
Progression-free survival
from randomising to progression, death, unacceptable AE
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02575378
Brief Title
Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer (mCRC) is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus Chinese Traditional Medicine.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic Colorectal Cancer, Maintenance Treatment, Chinese Traditional Medicine, Clinical Trial, efficacy, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metronomic chemotherapy
Arm Type
Other
Arm Description
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
Arm Title
Metronimic chemotherapy plus Chinese Traditional Medicine
Arm Type
Experimental
Arm Description
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
Chinese Traditional Medicine
Intervention Type
Drug
Intervention Name(s)
Metronimic chemotherapy plus Chinese Traditional Medicine
Intervention Description
Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine
Intervention Type
Drug
Intervention Name(s)
Metronimic chemotherapy
Intervention Description
Capecitabine 300mg/m2, twice a day, everyday
Primary Outcome Measure Information:
Title
Progression-free survival
Description
from randomising to progression, death, unacceptable AE
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unresectable metastatic colorectal cancer with pathological confirmation.
patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR.
Exclusion Criteria:
-
12. IPD Sharing Statement
Learn more about this trial
Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
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