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

July 11, 2020 updated by: Ding Ke-Feng, Zhejiang University

The Second Affiliated Hospital of Zhejiang University

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • The Affiliated Tumor Hospital of Zhongshan University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital Affiliated to Wuhan University
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital of Shanghai
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital of College of Medicine Zhejiang University
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospitalof Zhejiang University School of Medicine
      • Jinhua, Zhejiang, China, 321000
        • Jinhua People's Hospital
      • Ningbo, Zhejiang, China, 315010
        • The Second Hospital of Ningbo City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Raltitrexed-based chemotherapy
Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan
Drug: Raltitrexed-based chemotherapy
Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w
Other Names:
  • RTXOX
Drug: Raltitrexed-based chemotherapy
Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w
Other Names:
  • RTXIRI
Active Comparator: 5-fluorouracil-based chemotherapy
5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan
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
Other Names:
  • mFOLFOX6
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
Other Names:
  • FOLFIRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: 38 months
38 months

Secondary Outcome Measures

Outcome Measure
Time Frame
R0 resection rate of liver
Time Frame: 38 months
38 months

Other Outcome Measures

Outcome Measure
Time Frame
The side effects of the treatment
Time Frame: 38 months
38 months
The early tumor shrinkage （ETS）and depth of response(DPR)
Time Frame: 38 months
38 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Study Chair: Ding Ke-Feng, PHD/MD, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2015

Primary Completion (Actual)

September 11, 2018

Study Completion (Actual)

September 11, 2019

Study Registration Dates

First Submitted

May 17, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 25, 2015

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 11, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRCLM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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