Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer

Study Overview
=================
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.

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Metronimic chemotherapy plus Chinese Traditional Medicine
* Drug: Metronimic chemotherapy


Participation Criteria
=================
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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Metronomic chemotherapy<br>Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday. | Drug: Metronimic chemotherapy<br>* Capecitabine 300mg/m2, twice a day, everyday<br>|
| Experimental: Metronimic chemotherapy plus Chinese Traditional Medicine<br>Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday. Chinese Traditional Medicine | Drug: Metronimic chemotherapy plus Chinese Traditional Medicine<br>* Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | from randomising to progression, death, unacceptable AE | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Colorectal Cancer, Maintenance Treatment, Chinese Traditional Medicine, Clinical Trial, efficacy, safety