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Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer

NCT00593866 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-09-11

Study results available
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Summary

This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.

Conditions

Interventions

RADIATION

INTENSITY MODULATED RADIOTHERAPY

Five fractions weekly, fraction size determined by dose level

DRUG

Gemcitabine

1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

Sponsors & Collaborators

  • Rush University Medical Center

    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
2006-06-30
Primary Completion
2012-05-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00593866 on ClinicalTrials.gov