Back to resultsAlternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer
Primary Purpose
Resected Liver Metastases From Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)
Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)
Sponsored by
About this trial
This is an interventional treatment trial for Resected Liver Metastases From Colorectal Cancer
Eligibility Criteria
Diagnosis Criteria:
All patients should have histologically confirmed colorectal adenocarcinoma with hepatic metastases and primary tumours completely resected during the operation and with colorectal metastatic to the liver confirmed pathologically after the operation as well as with negative surgical margin.
Main criteria for inclusion:
- Aged 18-75 years
- Diagnosed as colorectal adenocarcinoma which only spread to the liver and with no extra-hepatic metastases
- Prior curative resection of primary tumours (R0 resection) or concurrent feasible curative resection of primary tumours and hepatic metastases (R0 resection is met)
- Performance status ECOG 0-1
- No serious complication occurred during or after metastases resection and affected subsequent treatment.
- Hematology: White blood count ≧ 4.0X10^9/L, Absolute neutrophil count ≧1.5X10^9/L, Platelet count ≧ 100 X10^9/L, Hemoglobin ≧ 100g/L
- Blood biochemistry: Total bilirubin ≦2mg/dL , Direct bilirubin equal or less than 1.5 times upper limit of normal (ULN), Alanine aminotransferase (ALT) no greater than 2.5 times ULN, Aspartate aminotransferase (AST) no greater than 2.5 times ULN, Serum creatinine no greater than ULN, or glomerular filtration rate equal or greater than 60 mL/min/1.73m^2
- Not pregnant or nursing at present
- Fertile patients must use effective contraception
- Able to withstand major operative procedure
- No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
- No prior hepatic artery infusion therapy with 5-FU or floxuridine
- No prior systemic chemotherapy for metastatic disease
- No other concurrent chemotherapy
- Able to understand and sign off informed consent form
Sites / Locations
- Fudan University Shanghai Cancer Center China
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Systemic Chemotherapy plus Hepatic Artery Infusion (HAI)
Systemic Chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival
Overall survival will be measured from the date of randomization up to the date of death of any cause
Liver Relapse-Free Survival Rate
Liver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first.
Secondary Outcome Measures
Disease free survival
DFS is defined as the time interval from the date of randomization to the time of the first relapse at any site, death from any cause, or last recorded follow-up visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02529774
Brief Title
Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer
Official Title
Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Controlled Phase II/III Trial in China
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ye Xu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resected Liver Metastases From Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
432 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Systemic Chemotherapy plus Hepatic Artery Infusion (HAI)
Arm Type
Experimental
Arm Title
Systemic Chemotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)
Intervention Description
Hepatic Artery Infusion for four cycles:
Floxuridine (FUDR) 500mg/d, Day 1-2; DXM 1mg/day added to FUDR 2-day infusion; Heparin 1000U/day added to FUDR 2-day infusion
In combination with Systemic Chemotherapy CapeOX for 8 cycles:
Oxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14
Or in combination with Systemic Chemotherapy mFOLFOX6 for 12 cycles:
Oxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)
Intervention Description
Systemic Chemotherapy CapeOX alone for 8 cycles:
Oxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14
Or Systemic Chemotherapy mFOLFOX6 alone for 12 cycles:
Oxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival will be measured from the date of randomization up to the date of death of any cause
Time Frame
5-year
Title
Liver Relapse-Free Survival Rate
Description
Liver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first.
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Disease free survival
Description
DFS is defined as the time interval from the date of randomization to the time of the first relapse at any site, death from any cause, or last recorded follow-up visit.
Time Frame
3-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis Criteria:
All patients should have histologically confirmed colorectal adenocarcinoma with hepatic metastases and primary tumours completely resected during the operation and with colorectal metastatic to the liver confirmed pathologically after the operation as well as with negative surgical margin.
Main criteria for inclusion:
Aged 18-75 years
Diagnosed as colorectal adenocarcinoma which only spread to the liver and with no extra-hepatic metastases
Prior curative resection of primary tumours (R0 resection) or concurrent feasible curative resection of primary tumours and hepatic metastases (R0 resection is met)
Performance status ECOG 0-1
No serious complication occurred during or after metastases resection and affected subsequent treatment.
Hematology: White blood count ≧ 4.0X10^9/L, Absolute neutrophil count ≧1.5X10^9/L, Platelet count ≧ 100 X10^9/L, Hemoglobin ≧ 100g/L
Blood biochemistry: Total bilirubin ≦2mg/dL , Direct bilirubin equal or less than 1.5 times upper limit of normal (ULN), Alanine aminotransferase (ALT) no greater than 2.5 times ULN, Aspartate aminotransferase (AST) no greater than 2.5 times ULN, Serum creatinine no greater than ULN, or glomerular filtration rate equal or greater than 60 mL/min/1.73m^2
Not pregnant or nursing at present
Fertile patients must use effective contraception
Able to withstand major operative procedure
No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
No prior hepatic artery infusion therapy with 5-FU or floxuridine
No prior systemic chemotherapy for metastatic disease
No other concurrent chemotherapy
Able to understand and sign off informed consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Xu, Dr.
Phone
+86 21 64175590
Email
xu_shirley021@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hongtu Zheng, Dr.
Phone
+86 180 1731 7711
Email
zht5863@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Xu, Dr.
Organizational Affiliation
Fudan University Shanghai Cancer Center China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Xu, Dr.
Phone
+86 21 64175590
Email
xu_shirley021@163.com
First Name & Middle Initial & Last Name & Degree
Hongtu Zheng, Dr.
Phone
+86 180 1731 7711
Email
zht5863@126.com
12. IPD Sharing Statement
Learn more about this trial
Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer
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