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OpenTrials
Completed

NCT Number: NCT00192712

Irinotecan, Gemcitabine and Radiation Therapy for 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.

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Key information

Conditions

Pancreatic Cancer Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Oncology, Rambam Medical Center

Haifa, 31096, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

irinotecan, gemcitabine

Drug

Primary outcomes

  1. time to treatment failure

Secondary outcomes

  1. response rate, survival, toxicity

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Phase II Study of Irinotecan and Gemcitabine (IrinoGem) Combined With 3-D Conformal Radiation Therapy for Locally Advanced Pancreatic Cancer

Important dates

Study start
2002
Study completion
2010
First posted
Sep 19, 2005
Registry last updated
Nov 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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