Back to resultsA Phase II Trial of Salvage Treatment With Gemcitabine and S-1 Combination in Patients With Heavily Treated Advanced Colorectal Cancer.
Primary Purpose
Advanced Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemcitabine/S-1
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Colorectal Cancer focused on measuring colorectal cancer, gemcitabine, S-1
Eligibility Criteria
Inclusion Criteria:
- non resectable colorectal adenocarcinoma.
- disease progression during or within 6months after treatment with irinotecan and oxaliplatin contaning regimens.
- estimated life expectancy of more than 3 months.
- ECOG status 2 or lower
Exclusion Criteria:
- other tumor type than adenoarcinoma.
- presence or history of CNS metastasis.
- evidence of gastrointestinal bleeding.
Sites / Locations
- Gachon University Gil Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine/ s-1
Arm Description
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
overall survival
number of participants with adverse events
Full Information
NCT ID
NCT01929421
First Posted
August 19, 2013
Last Updated
May 9, 2018
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01929421
Brief Title
A Phase II Trial of Salvage Treatment With Gemcitabine and S-1 Combination in Patients With Heavily Treated Advanced Colorectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
5. Study Description
Brief Summary
To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in metastatic colorectal cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Cancer
Keywords
colorectal cancer, gemcitabine, S-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine/ s-1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemcitabine/S-1
Primary Outcome Measure Information:
Title
Response rate
Time Frame
1year
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
1year
Title
number of participants with adverse events
Time Frame
1year
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:
non resectable colorectal adenocarcinoma.
disease progression during or within 6months after treatment with irinotecan and oxaliplatin contaning regimens.
estimated life expectancy of more than 3 months.
ECOG status 2 or lower
Exclusion Criteria:
other tumor type than adenoarcinoma.
presence or history of CNS metastasis.
evidence of gastrointestinal bleeding.
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Phase II Trial of Salvage Treatment With Gemcitabine and S-1 Combination in Patients With Heavily Treated Advanced Colorectal Cancer.
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