Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer

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. Identifier: NCT00192712
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 10, 2010
Information provided by:
Rambam Health Care Campus

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: irinotecan, gemcitabine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan and Gemcitabine (IrinoGem) Combined With 3-D Conformal Radiation Therapy for Locally Advanced Pancreatic Cancer
Study Start Date : November 2002
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. time to treatment failure

Secondary Outcome Measures :
  1. response rate, survival, toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192712

Department of Oncology, Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Ron Epelbaum, MD Identifier: NCT00192712     History of Changes
Other Study ID Numbers: RonIrinoGem.CTIL
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: November 10, 2010
Last Verified: September 2010

Keywords provided by Rambam Health Care Campus:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors