Stereotactic Body Radiation Therapy With or Without Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery
Recruitment status was: Recruiting
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.
|Pancreatic Cancer||Drug: gemcitabine hydrochloride Radiation: stereotactic body radiation therapy||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Margin-Intense Combination Therapy for Patients With Potentially Resectable Pancreatic Adenocarcinoma|
- Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection
- Postoperative surgical morbidity, defined as all other adverse events occurring within 90 days of surgery
- Total dose of chemotherapy and radiotherapy delivered
- 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
|Study Start Date:||October 2009|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Regimen 1
Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
Radiation: stereotactic body radiation therapy
Given as a single fraction
Experimental: 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.
Drug: gemcitabine hydrochloride
Given IVRadiation: stereotactic body radiation therapy
Given as a single fraction
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025882
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097|
|Principal Investigator:||John C. Mansour, MD||Simmons Cancer Center|
|OverallOfficial:||Marcella Aguilar||Simmons Cancer Center|