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

Metastatic Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02575378
• Other study ID #: ZHYY-ZYYZX-rjzl
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 10, 2015
• Last updated: October 13, 2015
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: October 2015
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Shanghai Association of Chinese Integrative Medicine:China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 159
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Metronimic chemotherapy plus Chinese Traditional Medicine
Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine
• Metronimic chemotherapy
Capecitabine 300mg/m2, twice a day, everyday

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	from randomising to progression, death, unacceptable AE	six months	No