Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Municipal Commission of Health and Family Planning | OTHER |
| Ruijin Hospital | OTHER |
| Fudan University | OTHER |
| Shanghai Zhongshan Hospital |
Not provided
Not provided
Not provided
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.
Gut microbiota are linked to chronic inflammation and carcinogenesis. Chemotherapy failure is the major cause of recurrence and poor prognosis in colorectal cancer patients. Previously in the investigators' research, the investigators find the contribution of gut microbiota to chemoresistance in patients with colorectal cancer. The investigators found that Fusobacterium nucleatum (Fn) was abundant in colorectal cancer tissues in patients with recurrence post chemotherapy, and was associated with patient clinicopathological characterisitcs. Furthermore, the investigators' bioinformatic and functional studies demonstrated that Fn promoted colorectal cancer resistance to chemotherapy. Metronidazole has been known to treat with anaerobe infection, including Fusobacterium. So 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole | Active Comparator | supplement 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 Comparator | supplement 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole Oral Tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival, DFS | The time from the initial surgical treatment of colorectal cancer to the earliest evidence of recurrence. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival, OS | The time from the initial surgical treatment of colorectal cancer to death from any cause. | 5 years |
| Recurrence Rate, RR | Percentage of patients who has recurrence during or after chemotherapy with Metronidazole or Placebo. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingyuan Fang, MD, PhD | Contact | 86-021-58752345 | jingyuanfang@sjtu.edu.cn | |
| Danfeng Sun, PhD | Contact | 86-021-58752345 | danfolsdf@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingyuan Fang, MD, PhD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | Recruiting | Shanghai | Shanghai Municipality | 200001 |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
Not provided
| OTHER |
| Shanghai Shen Kang Hospital Development Center | OTHER |
Not provided
Not provided
Not provided
Not provided
| Placebo oral tablet | Drug | 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. |
|
| 3 years, 5 years |
| China |
|
| Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 200025 | China |
|
| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Zhongshan Hospital affiliated to Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |