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Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer

NCT04264676 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2020-11-25

No results posted yet for this study

Summary

Fusobacterium nucleatum (Fusobacterium nucleatum, Fn) has been identified as an independent risk factor for recurrence of colorectal cancer. In this study, oral metronidazole would be used to reduce the abundance of Fn in patients with high Fn, so as to explore whether oral metronidazole can improve the efficacy of postoperative chemotherapy in patients with colorectal cancer.

Conditions

  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III

Interventions

DRUG

Metronidazole Oral Tablet

Supplement of metronidazole 0.4g three times per day for 7 days before each two cycles of chemotherapy (mFOLFOX6 once every 4 weeks, CapeOX once every 6 weeks), which is 6 treatments for mFOLFOX6 and 4 treatments for CapeOX totally.

DRUG

Placebo oral tablet

Supplement of placebo oral tablet 0.4g three times per day for 7 days before each two cycles of chemotherapy (mFOLFOX6 once every 4 weeks, CapeOX once every 6 weeks), which is 6 treatments for mFOLFOX6 and 4 treatments for CapeOX totally.

Sponsors & Collaborators

  • Shanghai Municipal Commission of Health and Family Planning

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Shanghai Shenkang Hospital Development Center

    collaborator UNKNOWN

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jingyuan Fang, MD, PhD · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2023-03-31
Completion
2025-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04264676 on ClinicalTrials.gov