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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Metronimic chemotherapy plus Chinese Traditional Medicine; Drug: Metronimic chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02575378

ZHYY-ZYYZX-rjzl

Details and patient eligibility

About

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.

Enrollment: 159 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 2 patient groups

Metronomic chemotherapy

Other group

Description:

Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.

Treatment:

Drug: Metronimic chemotherapy

Metronimic chemotherapy plus Chinese Traditional Medicine

Experimental group

Description:

Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday. Chinese Traditional Medicine

Treatment:

Drug: Metronimic chemotherapy plus Chinese Traditional Medicine