Clinical trial NCT00350142: Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer
Official title: Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Stereotactic Body Radiotherapy (SBRT)
pancreas cancer
locally advanced
local control
Gemcitabine
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:- Pancreatic tumors not to exceed 10 cm in greatest axial dimension

* Histologically confirmed malignancies of the pancreas
* Unresectable by CT criteria or exploratory laparotomy or laparoscopy
* Patients with metastatic disease may be treated if they are symptomatic from the primary tumor
* Performance status of 0, 1, or 2
* No chemotherapy two weeks prior or two weeks following radiosurgery

Exclusion Criteria:

* patients who have had prior radiotherapy to upper abdomen
* patients receiving any prior pancreatic cancer therapy
* children, pregnant, and breastfeeding women, and lab personnel are excluded
* uncontrolled intercurrent illnesses
* any concurrent malignancy

Primary outcomes:
measure: Rate of Local Control
timeFrame: up to 3 years
Secondary outcomes:
measure: Median Overall Survival Time
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Albert Koong
role: PRINCIPAL_INVESTIGATOR
References: