Back to resultsOxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
12 cycles of oxaliplatine based adjuvant chemotherapy
8 cycles of oxaliplatine based adjuvant chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring oxaliplatine, colorectal cancer, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- age < 75 years with histologically proven adenocarcinoma of the colon or rectum
- no severe major organ dysfunction
- WHO performance status of 0 or 1
- Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system)
Exclusion Criteria:
- age >= 75
- severe major organ dysfunction
- WHO performance status of >1
- Stage I or Stage IV
Sites / Locations
- Zhongshan Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
12 cycles of oxaliplatine based adjuvant chemotherapy
8 cycles of oxaliplatine based adjuvant chemotherapy
Outcomes
Primary Outcome Measures
disease-free survival
Secondary Outcome Measures
overall survival liver metastasis-free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00868816
Brief Title
Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles
Official Title
A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.
Detailed Description
We administered 5-FU, lv and Oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to patients with Stage II or Stage III colorectal cancer. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
oxaliplatine, colorectal cancer, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
12 cycles of oxaliplatine based adjuvant chemotherapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
8 cycles of oxaliplatine based adjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
12 cycles of oxaliplatine based adjuvant chemotherapy
Intervention Description
oxaliplatine 85 mg/㎡ d1, lv 200 mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 12 cycles
Intervention Type
Drug
Intervention Name(s)
8 cycles of oxaliplatine based adjuvant chemotherapy
Intervention Description
oxaliplatine 85 mg/㎡ d1, lv 200mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 8 cycles
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
5 years after operation
Secondary Outcome Measure Information:
Title
overall survival liver metastasis-free survival
Time Frame
5 years after operation
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:
age < 75 years with histologically proven adenocarcinoma of the colon or rectum
no severe major organ dysfunction
WHO performance status of 0 or 1
Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system)
Exclusion Criteria:
age >= 75
severe major organ dysfunction
WHO performance status of >1
Stage I or Stage IV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianmin xu, MD, PHD
Organizational Affiliation
department of general surgery, zhongshan hospital, fudan university
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles
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