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Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer

NCT00057876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-07-05

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

Conditions

Interventions

DRUG

Gemcitabine

Induction: Patients receive the first cycle of gemcitabine 1000 mg/m\^2 intravenously once per week for 6 weeks followed by 1 week rest. Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m\^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.

RADIATION

radiation therapy

Induction: Patients receive gemcitabine 600 mg/m\^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks. Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Radiation Therapy Oncology Group

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Patrick J. Loehrer, MD · Indiana University Melvin and Bren Simon Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-29
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States
  • South Africa

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 NCT00057876 on ClinicalTrials.gov