- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02688023
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
February 17, 2016 updated by: Jing Huang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing Huang, M.D.
- Phone Number: 8610-87788103
- Email: huangjingwg@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Jing Huang, M.D.
- Phone Number: 8610-87788103
- Email: huangjingwg@163.com
-
Principal Investigator:
- Zhixiang Zhou, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3-year disease-free survival
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 6 years
|
6 years
|
objective response rate
Time Frame: 2 years
|
2 years
|
Surgical complete resection rate (R0)
Time Frame: 2 years
|
2 years
|
Number of participants with adverse events that are related to treatment
Time Frame: 2 years
|
2 years
|
Number of participants with surgery complications
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jing Huang, M.D., Cancer hospital, CAMS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
February 11, 2016
First Submitted That Met QC Criteria
February 17, 2016
First Posted (Estimate)
February 23, 2016
Study Record Updates
Last Update Posted (Estimate)
February 23, 2016
Last Update Submitted That Met QC Criteria
February 17, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Micronutrients
- Vitamins
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Capecitabine
- Oxaliplatin
- Leucovorin
- Irinotecan
Other Study ID Numbers
- CH-GI-052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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