NCT02453490

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P25-P50 for phase_3 colorectal-cancer

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

October 11, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2019

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

2.9 years

First QC Date

May 17, 2015

Last Update Submit

July 11, 2020

Conditions

Colorectal CancerLiver Metastasis

Keywords

Colorectal Cancerliver metastasisneoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    38 months

Secondary Outcomes (1)

  • R0 resection rate of liver

    38 months

Other Outcomes (2)

  • The side effects of the treatment

    38 months

  • The early tumor shrinkage （ETS）and depth of response(DPR)

    38 months

Study Arms (2)

Raltitrexed-based chemotherapy

EXPERIMENTAL

Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan

Drug: Raltitrexed-based chemotherapy

5-fluorouracil-based chemotherapy

ACTIVE COMPARATOR

5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan

Drug: 5-fluorouracil-based chemotherapy

Interventions

Raltitrexed-based chemotherapyDRUG

Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w

Also known as: RTXOX
Raltitrexed-based chemotherapy
5-fluorouracil-based chemotherapyDRUG

5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d\*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w

Also known as: mFOLFOX6
5-fluorouracil-based chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis
  • previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year
  • Age of≥18 and ≤75
  • 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)
  • ECOG≤1
  • Life Expectancy\>6months
  • Signed written informed consent
  • Expected adequacy of follow-up

You may not qualify if:

  • Lesion is too small to assess by imaging
  • Extrahepatic metastases
  • Any anticancer chemotherapy in development within 4 weeks prior to study entry
  • Concurrent uncontrolled illness such as infection
  • Be allergic to medicines in the study
  • Pregnant or nursing patients
  • Fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
  • Not willing or incapable to comply with all study visits and assessments
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The Affiliated Tumor Hospital of Zhongshan University

Guangzhou, Guangdong, 510060, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Zhongnan Hospital Affiliated to Wuhan University

Wuhan, Hubei, 430071, China

Location

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200433, China

Location

The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Second Affiliated Hospitalof Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Jinhua People's Hospital

Jinhua, Zhejiang, 321000, China

Location

The second hospital of Ningbo City

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

IFL protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ding Ke-Feng, PHD/MD

    Zhejiang University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the Second Affiliated Hospital of Zhejiang University

Study Record Dates

First Submitted

May 17, 2015

First Posted

May 25, 2015

Study Start

October 11, 2015

Primary Completion

September 11, 2018

Study Completion

September 11, 2019

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

CN(9)