Back to resultsNeoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring 5-fluorouracil, Irinotecan, Oxaliplatin, Colorectal cancer, neoadjuvant, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- histologically verified colorectal cancer
- clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
- age: 18-70 years
- ECOG 0-2
- adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
- no prior cancer and/or chemotherapy
- signed informed consent
Exclusion Criteria:
- patients with a history of prior malignancy
- pregnant or lactating patients
- known or suspected brain metastasis
Sites / Locations
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
Arm Description
Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
Outcomes
Primary Outcome Measures
3-year disease-free survival
Secondary Outcome Measures
objective response rate
Surgical complete resection rate (R0)
overall survival
Number of participants with adverse events that are related to treatment
Number of participants with surgery complications
Full Information
NCT ID
NCT02688023
First Posted
February 11, 2016
Last Updated
February 17, 2016
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02688023
Brief Title
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
Official Title
A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.
Detailed Description
This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
5-fluorouracil, Irinotecan, Oxaliplatin, Colorectal cancer, neoadjuvant, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
Arm Type
Experimental
Arm Description
Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
Intervention Type
Drug
Intervention Name(s)
oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
Intervention Description
The regimen consisted of irinotecan 150mg/m2 administered as an intravenous infusion on day 1, oxaliplatin 85 mg/m2 administered intravenously on day 2, leucovorin 200 mg intravenously on day 2, 5-fluorouracil 500 mg administered by intravenous bolus,followed by 2400 mg/m2 by 44 h continuous intravenous infusion starting on day 2. S-1 (40-60mg orally twice per day for 10 days) or capecitabine (1000mg/m2 orally twice per day for 10 days) can be substituted for intravenous 5-fluorouracil.14 days as a cycle, up to 4 cycles.
Primary Outcome Measure Information:
Title
3-year disease-free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
objective response rate
Time Frame
2 years
Title
Surgical complete resection rate (R0)
Time Frame
2 years
Title
overall survival
Time Frame
6 years
Title
Number of participants with adverse events that are related to treatment
Time Frame
2 years
Title
Number of participants with surgery complications
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically verified colorectal cancer
clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
age: 18-70 years
ECOG 0-2
adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
no prior cancer and/or chemotherapy
signed informed consent
Exclusion Criteria:
patients with a history of prior malignancy
pregnant or lactating patients
known or suspected brain metastasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Huang, M.D.
Phone
8610-87788103
Email
huangjingwg@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Huang, M.D.
Organizational Affiliation
Cancer Hospital, CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Huang, M.D.
Phone
8610-87788103
Email
huangjingwg@163.com
First Name & Middle Initial & Last Name & Degree
Zhixiang Zhou, M.D.
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
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