Phase I/II Radiotherapy Dose Escalation Study in Locally Advanced Pancreatic Cancer, Using a Simultaneous Intensity Modulated Boost With Concurrent Gemcitabine
- 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).
- 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.
After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 2 years, and then annually thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of intensity-modulated radiotherapy (Phase I)
Salma Jabbour, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|