Margin-Intense Combo Therapy in Pts w/Potentially Resectable Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Radiation: stereotactic body radiation therapy
- Registration Number
- NCT01025882
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Regimen 1 stereotactic body radiation therapy Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43. Regimen 2 gemcitabine hydrochloride 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. Regimen 2 stereotactic body radiation therapy 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.
- Primary Outcome Measures
Name Time Method Postoperative surgical morbidity, defined as all other adverse events occurring within 90 days of surgery Pre-treatment and post-treatment characteristics of the primary tumor on preoperative axial imaging including, but not limited to, tumor size, percentage of encasement/abutment of mesenteric vessels, and progression of disease Postoperative complications including, but not limited to, need for reoperation, need for interventional radiology fluid collection drainage, systemic infection, wound infection, prolonged ICU stay, and delayed gastric emptying Operative drain amylase at days 3 and 5 postoperatively Length of hospital stay following pancreatic resection Degree of histologic response of tumor in the resected specimen Tumor samples for RNA and protein harvesting (when possible) from pretreatment biopsies and surgical specimens Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection Total dose of chemotherapy and radiotherapy delivered
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States