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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02575378

Enrollment

159

Registered

2015-10-14

Start date

2015-09-30

Completion date

2018-12-31

Last updated

2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer, Maintenance Treatment, Chinese Traditional Medicine, Clinical Trial, efficacy, safety

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.

Interventions

DRUGMetronimic chemotherapy plus Chinese Traditional Medicine

Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine

DRUGMetronimic chemotherapy

Capecitabine 300mg/m2, twice a day, everyday

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026