Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

NCT00456599 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2015-12-03

Study results available
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Summary

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Conditions

Interventions

DRUG

gemcitabine

Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle.

DRUG

oxaliplatin

Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle.

PROCEDURE

Radiation

The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY
  • Johns Hopkins University

    collaborator OTHER
  • Princess Margaret Hospital, Canada

    collaborator OTHER
  • Ohio State University

    collaborator OTHER
  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Mark Zalupski, MD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2012-05-31
Completion
2013-01-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00456599 on ClinicalTrials.gov