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

Phase 4

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Metronimic chemotherapy; Drug: Metronimic chemotherapy plus Chinese Traditional Medicine

• Registration Number: NCT02575378
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2015-10
• Study First Submitted: 2015-10-10
• Study First Submitted QC: 2015-10-13
• Last Update Submitted: 2015-10-13
• Study First Posted: 2015-10-14
• Last Update Posted: 2015-10-14
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronomic chemotherapy	Metronimic chemotherapy	Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
Metronimic chemotherapy plus Chinese Traditional Medicine	Metronimic chemotherapy plus Chinese Traditional Medicine	Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday. Chinese Traditional Medicine

Primary Outcome Measures

Name	Time	Method
Progression-free survival	six months	from randomising to progression, death, unacceptable AE