Back to resultsCompare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis
Primary Purpose
Colorectal Cancer, Liver Metastasis
Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Raltitrexed-based chemotherapy
Raltitrexed-based chemotherapy
5-fluorouracil-based chemotherapy
5-fluorouracil-based chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, liver metastasis, neoadjuvant chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- The Affiliated Tumor Hospital of Zhongshan University
- Wuhan Union Hospital
- Zhongnan Hospital Affiliated to Wuhan University
- Changhai Hospital of Shanghai
- The First Affiliated Hospital of College of Medicine Zhejiang University
- Second Affiliated Hospitalof Zhejiang University School of Medicine
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
- Jinhua People's Hospital
- The second hospital of Ningbo City
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Raltitrexed-based chemotherapy
5-fluorouracil-based chemotherapy
Arm Description
Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan
5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan
Outcomes
Primary Outcome Measures
Objective response rate
Secondary Outcome Measures
R0 resection rate of liver
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02453490
Brief Title
Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis
Official Title
The Second Affiliated Hospital of Zhejiang University
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
difficultly recruiting
Study Start Date
October 11, 2015 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Metastasis
Keywords
Colorectal Cancer, liver metastasis, neoadjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Raltitrexed-based chemotherapy
Arm Type
Experimental
Arm Description
Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan
Arm Title
5-fluorouracil-based chemotherapy
Arm Type
Active Comparator
Arm Description
5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan
Intervention Type
Drug
Intervention Name(s)
Raltitrexed-based chemotherapy
Other Intervention Name(s)
RTXOX
Intervention Description
Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w
Intervention Type
Drug
Intervention Name(s)
Raltitrexed-based chemotherapy
Other Intervention Name(s)
RTXIRI
Intervention Description
Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil-based chemotherapy
Other Intervention Name(s)
mFOLFOX6
Intervention Description
5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil-based chemotherapy
Other Intervention Name(s)
FOLFIRI
Intervention Description
5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
38 months
Secondary Outcome Measure Information:
Title
R0 resection rate of liver
Time Frame
38 months
Other Pre-specified Outcome Measures:
Title
The side effects of the treatment
Time Frame
38 months
Title
The early tumor shrinkage （ETS）and depth of response(DPR)
Time Frame
38 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Ke-Feng, PHD/MD
Organizational Affiliation
Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Tumor Hospital of Zhongshan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Zhongnan Hospital Affiliated to Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Second Affiliated Hospitalof Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Jinhua People's Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Facility Name
The second hospital of Ningbo City
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
12. IPD Sharing Statement
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Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis
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