Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis
NCT02453490 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2020-07-14
Summary
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).
Conditions
- Colorectal Cancer
- Liver Metastasis
Interventions
- DRUG
-
Raltitrexed-based chemotherapy
Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w
- DRUG
-
Raltitrexed-based chemotherapy
Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w
- DRUG
-
5-fluorouracil-based chemotherapy
5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d\*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w
- DRUG
-
5-fluorouracil-based chemotherapy
5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d\*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w
Sponsors & Collaborators
-
Zhejiang University
lead OTHER
Principal Investigators
-
Ding Ke-Feng, PHD/MD · Zhejiang University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-11
- Primary Completion
- 2018-09-11
- Completion
- 2019-09-11
Countries
- China
Study Locations
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