Not provided
Not provided
Not provided
Not provided
Not provided
difficultly recruiting
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).
The contrast analysis is separately done on Raltitrexed plus oxaliplatin and 5-fluorouracil plus oxaliplatin;Raltitrexed plus irinotecan and 5-fluorouracil plus irinotecan.To investigate the objective response rate,the R0 resection rate, the early tumor shrinkage (ETS)and depth of response(DPR) and the safety profile.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltitrexed-based chemotherapy | Experimental | Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan |
|
| 5-fluorouracil-based chemotherapy | Active Comparator | 5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltitrexed-based chemotherapy | Drug | Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 38 months |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate of liver | 38 months |
| Measure | Description | Time Frame |
|---|---|---|
| The side effects of the treatment | 38 months | |
| The early tumor shrinkage (ETS)and depth of response(DPR) | 38 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ding Ke-Feng, PHD/MD | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Tumor Hospital of Zhongshan University | Guangzhou | Guangdong | 510060 | China | ||
| Wuhan Union Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Raltitrexed-based chemotherapy | Drug | Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w |
|
|
| 5-fluorouracil-based chemotherapy | Drug | 5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w |
|
|
| 5-fluorouracil-based chemotherapy | Drug | 5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w |
|
|
| Wuhan |
| Hubei |
| 430022 |
| China |
| Zhongnan Hospital Affiliated to Wuhan University | Wuhan | Hubei | 430071 | China |
| Changhai Hospital of Shanghai | Shanghai | Shanghai Municipality | 200433 | China |
| The First Affiliated Hospital of College of Medicine Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Second Affiliated Hospitalof Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Jinhua People's Hospital | Jinhua | Zhejiang | 321000 | China |
| The second hospital of Ningbo City | Ningbo | Zhejiang | 315010 | China |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C480833 | IFL protocol |
Not provided
Not provided
Not provided