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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453490 on ClinicalTrials.gov