Back to resultsFOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring FOLFIRI, FOLFOX, adjuvant chemotherapy, advanced colorectal cancer
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed adenocarcinoma in colorectal cancer
- clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined
- no cancer cells were found in ascites
- Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
- male or female, between 18 and 75 years old
- adequate hematologic, hepatic and renal functions
- without severe heart disease in the last 6 months before enrolled. If with hypertension or coronary artery disease, it can be controlled
- not enrolled into others clinical trial during this study
- all patients should sign the informed consent
Exclusion Criteria:
- can not be tolerated operation
- receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study
- can not be tolerated the adverse effect of drugs in these regimens
- major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery
- metastatic disease more than one organ
- pregnant or lactating women
Sites / Locations
- the first affiliated hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
FOLFOX
FOLFIRI
Arm Description
In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.
in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles
Outcomes
Primary Outcome Measures
disease-free survival（DFS）
The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.
Secondary Outcome Measures
overall survival(OS)
The 5-year survival rate will be the secondary end point. The investigator will follow up the patients and campare the difference of 5-year-OS between the two groups.
Full Information
NCT ID
NCT01566942
First Posted
March 26, 2012
Last Updated
March 27, 2012
Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01566942
Brief Title
FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer
Official Title
FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
FOLFIRI, FOLFOX, adjuvant chemotherapy, advanced colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFOX
Arm Type
Active Comparator
Arm Description
In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.
Arm Title
FOLFIRI
Arm Type
Experimental
Arm Description
in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
In this arm, patients will receive the adjuvant chemotherapy with mFOLFOX6 regimen for 8 cycles. Oxaliplatin 85mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
In this arm, patients will receive the adjuvant chemotherapy with FOLFIRI regimen for 8 cycles. Irinotecan 180mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks
Primary Outcome Measure Information:
Title
disease-free survival（DFS）
Description
The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.
Time Frame
3-year disease-free survival rate
Secondary Outcome Measure Information:
Title
overall survival(OS)
Description
The 5-year survival rate will be the secondary end point. The investigator will follow up the patients and campare the difference of 5-year-OS between the two groups.
Time Frame
5-year survival
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 adenocarcinoma in colorectal cancer
clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined
no cancer cells were found in ascites
Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
male or female, between 18 and 75 years old
adequate hematologic, hepatic and renal functions
without severe heart disease in the last 6 months before enrolled. If with hypertension or coronary artery disease, it can be controlled
not enrolled into others clinical trial during this study
all patients should sign the informed consent
Exclusion Criteria:
can not be tolerated operation
receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study
can not be tolerated the adverse effect of drugs in these regimens
major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery
metastatic disease more than one organ
pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YULONG HE, PhD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
the first affiliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JIANJUN PENG, PhD
Phone
86-20-87332200
Ext
8211
Email
aidigua@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer
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