NCT00350142

Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Albert Koong · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine

Detailed description

In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy may prolong the interval to distant progression and improve overall survival in these patients. In this study, we will treat pancreatic cancer patients with locally advanced disease with 3 weeks of gemcitabine, followed by Trilogy(TM) SBRT and additional gemcitabine. 30 patients will be accrued to this study at Stanford University Medical Center, the only site participating in this research study. Treatment on this protocol requires placement of 3-5 gold (99.9% pure) fiducials for targeting purposes. Four to 7 days after placement of the fiducials, patients will then undergo a 4D pancreatic protocol CT scan through the upper abdomen. In addition, an FDG PET scan is required for treatment planning purposes. This imaging set will be processed for radiosurgery, using a modified linac based radiation treatment planning system (EclipseTM). An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy prescribed to the isodose line that completely surrounds the gross pancreatic tumor volume (GTV) as defined by the contrast CT. Following SBRT, patients will be monitored clinically and radiographically.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiotherapy	Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator
DRUG	Gemcitabine	Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes
OTHER	4D pancreatic protocol CT scan	Patients will undergo this imaging procedure prior to treatment for planning purposes.
RADIATION	FDG PET scan	Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-07-10
• Last updated: 2017-02-14
• Results posted: 2014-08-22

Locations

1 site across 1 country: United States