A Randomized Trial Comparing 5-Fluorouracil, External Beam Radiation, and Gemcitabine With or Without P Radiopharmaceutical Therapy As A First Line Therapy in Patients With Locally/Regionally Advanced Non-Resectable Adenocarcinoma of the Pancreas
- Compare the survival of patients with locally or regionally advanced unresectable
adenocarcinoma of the pancreas treated with fluorouracil, external beam radiotherapy,
and gemcitabine with vs without brachytherapy with phosphorus P32 suspension.
- Compare time to disease progression, tumor response rate, and physical performance in
patients treated with these regimens.
- Compare the safety and tolerability of these regimens in this patient population.
- Compare duration of response and time to treatment failure in patients treated with
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive phosphorus P32 suspension percutaneously under CT guidance on
day 0 and at months 1, 2, 6, 7, and 8. Patients receive fluorouracil IV continuously on
days 1-5 of weeks 1-6. Patients concurrently undergo external beam radiotherapy 5 days
a week on weeks 1-6. At the completion of radiotherapy, patients receive gemcitabine IV
over 30 minutes once weekly for 7 weeks. After a 1-week rest, patients then receive
gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment repeats every 28
- Arm II: Patients receive fluorouracil and gemcitabine and undergo external beam
radiotherapy as in arm I.
In both arms, treatment continues in the absence of disease progression or unacceptable
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
study within 24-30 months.
Allocation: Randomized, Primary Purpose: Treatment
Alexander Rosemurgy, MD
University of South Florida
United States: Federal Government
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