Colorectal Cancer Stage III Clinical Trial
Official title:
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.
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.
Status | Recruiting |
Enrollment | 294 |
Est. completion date | March 2025 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 - Individuals with any conditions that the researchers considered inappropriate for inclusion |
Country | Name | City | State |
---|---|---|---|
China | 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 |
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
China | Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
China | Zhongshan Hospital affiliated to Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine | Fudan University, Ruijin Hospital, Shanghai Municipal Commission of Health and Family Planning, Shanghai Shenkang Hospital Development Center, Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease Free Survival, DFS | The time from the initial surgical treatment of colorectal cancer to the earliest evidence of recurrence. | 5 years | |
Secondary | Overall Survival, OS | The time from the initial surgical treatment of colorectal cancer to death from any cause. | 5 years | |
Secondary | Recurrence Rate, RR | Percentage of patients who has recurrence during or after chemotherapy with Metronidazole or Placebo. | 3 years, 5 years |
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