Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
irinotecan, gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring carcinoma, pancreas, chemotherapy, radiotherapy
Eligibility Criteria
Inclusion Criteria: locally advanced pancreatic cancer performance status 0-2 normal blood count and chemistry no previous chemotherapy or radiotherapy Exclusion Criteria: serious concurrent systemic disease
Sites / Locations
- Department of Oncology, Rambam Medical Center
Outcomes
Primary Outcome Measures
time to treatment failure
Secondary Outcome Measures
response rate, survival, toxicity
Full Information
NCT ID
NCT00192712
First Posted
September 11, 2005
Last Updated
November 9, 2010
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT00192712
Brief Title
Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer
Official Title
Phase II Study of Irinotecan and Gemcitabine (IrinoGem) Combined With 3-D Conformal Radiation Therapy for Locally Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
5. Study Description
Brief Summary
The study hypothesis is that chemoradiation based on 2 drugs will improve local control and long-term survival in patients with locally advanced pancreatic cancer. That is why gemcitabine and irinotecan are combined in an induction phase of 2 months and then this IrinoGem combination is given for 3 more cycles, in reduced doses,concurently with irradiation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
carcinoma, pancreas, chemotherapy, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
irinotecan, gemcitabine
Primary Outcome Measure Information:
Title
time to treatment failure
Secondary Outcome Measure Information:
Title
response rate, survival, toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
locally advanced pancreatic cancer
performance status 0-2
normal blood count and chemistry
no previous chemotherapy or radiotherapy
Exclusion Criteria:
serious concurrent systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Epelbaum, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer
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