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Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192712
First Posted: September 19, 2005
Last Update Posted: November 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
September 11, 2005
September 19, 2005
November 10, 2010
November 2002
Not Provided
time to treatment failure
Same as current
Complete list of historical versions of study NCT00192712 on ClinicalTrials.gov Archive Site
response rate, survival, toxicity
Same as current
Not Provided
Not Provided
 
Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer
Phase II Study of Irinotecan and Gemcitabine (IrinoGem) Combined With 3-D Conformal Radiation Therapy for Locally Advanced Pancreatic Cancer
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
Drug: irinotecan, gemcitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2010
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00192712
RonIrinoGem.CTIL
Not Provided
Not Provided
Not Provided
Not Provided
Rambam Health Care Campus
Not Provided
Principal Investigator: Ron Epelbaum, MD
Rambam Health Care Campus
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP