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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
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring carcinoma, pancreas, chemotherapy, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 11, 2005
Last Updated
November 9, 2010
Sponsor
Rambam Health Care Campus
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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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