Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer
Fusobacterium Nucleatum Eradication in Postoperative Stage II/III Colorectal Cancer(FINER-PACE)by Oral Metronidazole: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
1 other identifier
interventional
294
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2020
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedStudy Start
First participant enrolled
March 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedNovember 25, 2020
November 1, 2020
2.9 years
February 8, 2020
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Free Survival, DFS
The time from the initial surgical treatment of colorectal cancer to the earliest evidence of recurrence.
5 years
Secondary Outcomes (2)
Overall Survival, OS
5 years
Recurrence Rate, RR
3 years, 5 years
Study Arms (2)
Metronidazole
ACTIVE COMPARATORsupplement of metronidazole 0.4g three times per day for 7 days, which is one treatment every 4 weeks for mFOLFOX6(6 treatments totally),and every 6 weeks for CapeOX (4 treatments totally).
Placebo
PLACEBO COMPARATORsupplement of identical-appearing placebo 0.4g three times per day for 7 days, which is one treatment every 4 weeks for mFOLFOX6 (6 treatments totally),and every 6 weeks for CapeOX 4 treatments totally).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Individuals aged 18-75 years
- Individuals firstly confirmed by surgery pathology as colorectal cancer (AJCC cancer staging II - III), who need mFOLFOX6 or CapeOX postoperative chemotherapy
- Individuals with Fn - deltaCT value in colon tissue samples detected by qPCR ≥-12 before receiving chemotherapy
- Individuals who could tolerate chemotherapy drugs: ECOG (Eastern Cooperative Oncology Group) score ≤2 points, WBC(White Blood Cell) ≥4.0×10\^9/L, Hb （Hemoglobin） ≥80g/L, PLT （Platelet） ≥80×10\^9/L, ALT （Alanine Aminotransferase）\< 2ULN （Upper Limmit of Normal）, Scr （Creatinine）\< 1.5ULN
- Individuals who participate this study and sign the informed consent form willingly.
You may not qualify if:
- Individuals with colorectal adenoma or non-colorectal cancer, such as inflammatory bowel disease
- Individuals with a history of familial adenomatous polyposis (FAP)
- Individuals with severe heart, lung, brain, kidney, gastrointestinal or systemic diseases
- Individuals who used antibiotics for more than 5 days in 1 month prior to chemotherapy
- Individuals with stage I or IV colorectal cancer, or with stage II colorectal cancer who do not need postoperative chemotherapy
- Individuals with contraindications for metronidazole
- Individuals who unwilling to participate this study，or unwilling to sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Jiao Tong University School of Medicinelead
- Shanghai Municipal Commission of Health and Family Planningcollaborator
- Ruijin Hospitalcollaborator
- Fudan Universitycollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Shanghai Shenkang Hospital Development Centercollaborator
Study Sites (4)
Division of Gastroenterology and Hepatology, Ren-Ji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai Institute of Digestive Disease; Key Laboratory of Gastroenterology & Hepatology, Ministry of Health
Shanghai, Shanghai Municipality, 200001, China
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jingyuan Fang, MD, PhD
Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Gastroenterology
Study Record Dates
First Submitted
February 8, 2020
First Posted
February 11, 2020
Study Start
March 31, 2020
Primary Completion
March 1, 2023
Study Completion
March 1, 2025
Last Updated
November 25, 2020
Record last verified: 2020-11