Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer
| Status: | Archived |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2009 |
Phase I/II Radiotherapy Dose Escalation Study in Locally Advanced Pancreatic Cancer, Using a Simultaneous Intensity Modulated Boost With Concurrent Gemcitabine
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to
the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in
chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. Giving intensity-modulated
radiation therapy together with gemcitabine may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of
intensity-modulated radiation therapy and to see how well it works when given together with
gemcitabine in treating patients with locally advanced pancreatic cancer.
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.
After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 2 years, and then annually thereafter.
We found this trial at
1
site
New Brunswick, New Jersey 08903
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