Phase I/II Radiotherapy Dose Escalation Study in Locally Advanced Pancreatic Cancer, Using a Simultaneous Intensity Modulated Boost With Concurrent Gemcitabine

The study was terminated early due to slow accrual and only the phase I portion of hte study was opened. The phase of the study has been revised to only a phase I study.

OBJECTIVES:

• To determine the maximum tolerated dose (MTD) of intensity-modulated radiotherapy delivered to the gross tumor volume when administered with gemcitabine hydrochloride in patients with locally advanced pancreatic carcinoma. (Phase I)
• To define the dose-limiting toxicities of this regimen in these patients. (Phase I)
• To determine the local control in patients treated at the MTD (determined in phase I). (Phase II)
• To compare the disease-free survival and time to progression in these patients with that of historical controls. (Phase II)

OUTLINE: This is a multicenter phase I, dose-escalation study of intensity-modulated radiotherapy, followed by a phase II study.

• Induction chemotherapy: Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo CT scan. Patients with no evidence of metastatic disease proceed to chemoradiotherapy.
• Chemoradiotherapy: Beginning 1-2 weeks after completion of induction chemotherapy, patients undergo intensity-modulated radiotherapy once daily 5 days a week and gemcitabine hydrochloride IV over 30 minutes once weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease remains unresectable proceed to adjuvant chemotherapy.
• Adjuvant chemotherapy: Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive gemcitabine hydrochloride as in induction chemotherapy.