Pancreatic Cancer Clinical Trial
Official title:
Phase I Study of Margin-Intense Combination Therapy for Patients With Potentially Resectable Pancreatic Adenocarcinoma
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the
tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine
hydrochloride, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Giving stereotactic body radiation therapy
together with gemcitabine hydrochloride may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of stereotactic body radiation
therapy when given with or without gemcitabine hydrochloride in treating patients with
pancreatic cancer that can be removed by surgery.
OBJECTIVES:
- To demonstrate the feasibility and safety of administering margin-intensive stereotactic
body radiotherapy together with preoperative gemcitabine hydrochloride to patients with
resectable pancreatic adenocarcinoma.
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine hydrochloride. Patients
receive 1 of 2 treatment regimens.
- Regimen 1: Patients undergo a single fraction of margin-intensive stereotactic body
radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
- Regimen 2: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8,
and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by
pancreatoduodenectomy between days 35-63.
After completion of study treatment, patients are followed periodically for 5 years.
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