Overview

This trial is active, not recruiting.

Condition metastatic colorectal cancer
Treatments metronimic chemotherapy plus chinese traditional medicine, metronimic chemotherapy
Phase phase 4
Sponsor Ruijin Hospital
Start date September 2015
End date June 2018
Trial size 159 participants
Trial identifier NCT02575378, ZHYY-ZYYZX-rjzl

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
metronimic chemotherapy
Capecitabine 300mg/m2, twice a day, everyday
(Experimental)
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

Primary Outcomes

Measure
Progression-free survival
time frame: six months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. unresectable metastatic colorectal cancer with pathological confirmation. 2. patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. Exclusion Criteria:

Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Ruijin Hospital.