Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00192712
First received: September 11, 2005
Last updated: November 9, 2010
Last verified: September 2010

September 11, 2005
November 9, 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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00192712
RonIrinoGem.CTIL
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