NCT00878657

Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	Pre-Chemoradiation (Induction) Chemotherapy Gemcitabine will be given weekly for seven doses at a dose of 1000 mg/m2/wk (Days 1, 8, 15, 22, 29, 36, 43) unless toxicity develops. Chemoradiation gemcitabine will be given 400 mg/m2, infused over 30 minutes, within 120 minutes before radiotherapy. Post-chemoradiation chemotherapy, patients will receive two cycles of gemcitabine. A cycle will be defined as three weeks of gemcitabine at 1000 mg/m2/d, once weekly, followed by a one-week rest.
RADIATION	intensity-modulated radiation therapy	Dose escalation levels (cohorts) for this study: Dose Level 1: GTV plus drainage areas 45 Gy, Boost GTV 50.4 Gy Dose Level 2: GTV plus drainage areas 45 Gy, Boost GTV 54.0 Gy Dose Level 3: GTV plus drainage areas 45 Gy, Boost GTV 59.4 Gy Dose Level 4: GTV plus drainage areas 45 Gy, Boost GTV 64.8 Gy Dose Level 5: GTV plus drainage areas 45 Gy, Boost GTV 70.2 Gy

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-10-01
• Completion: 2013-10-01
• First posted: 2009-04-09
• Last updated: 2014-05-05

Locations

1 site across 1 country: United States