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

Phase 3

Terminated

• Conditions: Colorectal Cancer; Liver Metastasis
• Interventions: Drug: Raltitrexed-based chemotherapy; Drug: 5-fluorouracil-based chemotherapy

• Registration Number: NCT02453490
• Lead Sponsor: Zhejiang University

Brief 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.

Study Timeline

• Study First Submitted: 2015-05-17
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-25
• Study Start: 2015-10-11
• Primary Completion: 2018-09-11
• Study Completion: 2019-09-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-11
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis
2. previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year
3. Age of≥18 and ≤75
4. Adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/L, platelets 100 x 109/L, White blood cells 4 x 109/L), liver function (serum bilirubin ≤ 2.5 x ULN, serum transaminases ≤2. 5x ULN)
5. ECOG≤1
6. Life Expectancy>6months
7. Signed written informed consent
8. Expected adequacy of follow-up

Exclusion Criteria

1. Lesion is too small to assess by imaging
2. Extrahepatic metastases
3. Any anticancer chemotherapy in development within 4 weeks prior to study entry
4. Concurrent uncontrolled illness such as infection
5. Be allergic to medicines in the study
6. Pregnant or nursing patients
7. Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
8. Not willing or incapable to comply with all study visits and assessments
9. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raltitrexed-based chemotherapy	Raltitrexed-based chemotherapy	Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan
5-fluorouracil-based chemotherapy	5-fluorouracil-based chemotherapy	5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan

Primary Outcome Measures

Name	Time	Method
Objective response rate	38 months

Secondary Outcome Measures

Name	Time	Method
R0 resection rate of liver	38 months

Trial Locations

Locations (9)

The Affiliated Tumor Hospital of Zhongshan University; 🇨🇳 Guangzhou, Guangdong, China

Zhongnan Hospital Affiliated to Wuhan University; 🇨🇳 Wuhan, Hubei, China

Changhai Hospital of Shanghai; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of College of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Second Affiliated Hospitalof Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Jinhua People's Hospital; 🇨🇳 Jinhua, Zhejiang, China

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

The second hospital of Ningbo City; 🇨🇳 Ningbo, Zhejiang, China