Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
1 other identifier
interventional
159
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2015
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 10, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 14, 2015
October 1, 2015
2.8 years
October 10, 2015
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
from randomising to progression, death, unacceptable AE
six months
Study Arms (2)
Metronomic chemotherapy
OTHERMetronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
Metronimic chemotherapy plus Chinese Traditional Medicine
EXPERIMENTALMetronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday. Chinese Traditional Medicine
Interventions
Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine
Eligibility Criteria
You may qualify if:
- unresectable metastatic colorectal cancer with pathological confirmation.
- patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate chief physician, Department of Oncology
Study Record Dates
First Submitted
October 10, 2015
First Posted
October 14, 2015
Study Start
September 1, 2015
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
October 14, 2015
Record last verified: 2015-10