NCT02453490

Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis

The Second Affiliated Hospital of Zhejiang University

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Colorectal Cancer
• Liver Metastasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-10-11
• Primary completion: 2018-09-11
• Completion: 2019-09-11
• First posted: 2015-05-25
• Last updated: 2020-07-14

Locations

9 sites across 1 country: China