Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

Albert Koong

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Radiation: FDG PET scan; Radiation: Stereotactic Body Radiotherapy; Other: 4D pancreatic protocol CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT00350142

PANC0005 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Stereotactic Body Radiotherapy

Experimental group

Description:

Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.

Treatment:

Other: 4D pancreatic protocol CT scan

Radiation: Stereotactic Body Radiotherapy

Radiation: FDG PET scan

Drug: Gemcitabine