Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

NCT ID: NCT00350142

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-10-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic Body Radiotherapy

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.

Group Type: EXPERIMENTAL

Stereotactic Body Radiotherapy

Intervention Type: RADIATION

Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator

Gemcitabine

Intervention Type: DRUG

Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes

4D pancreatic protocol CT scan

Intervention Type: OTHER

Patients will undergo this imaging procedure prior to treatment for planning purposes.

FDG PET scan

Intervention Type: RADIATION

Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.

Interventions

Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator

Intervention Type: RADIATION

Gemcitabine

Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes

Intervention Type: DRUG

4D pancreatic protocol CT scan

Patients will undergo this imaging procedure prior to treatment for planning purposes.

Intervention Type: OTHER

FDG PET scan

Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.

Intervention Type: RADIATION

Other Intervention Names

single fraction 25 Gy dose Stereotactic Body Radiotherapy; Gemzar; computerized tomography scan; Fluorodeoxyglucose (FDG)-positron emission tomography

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Koong

OTHER

Sponsor Role: lead

Responsible Party

Albert Koong

Associate Professor of Radiation Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Albert Koong

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

PANC0005

Identifier Type: OTHER

Identifier Source: secondary_id

PANC0005

Identifier Type: -

Identifier Source: org_study_id