Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Fluorodeoxyglucose F18

Pancrelipase

Pancreatin

Antimetabolites

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.

Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator

Stereotactic Body Radiotherapy

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

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

4D pancreatic protocol CT scan

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

FDG PET scan

Albert Koong

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

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.

Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

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

The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site.

Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression.

The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves.

Associate Professor of Radiation Oncology

patient with locally advanced pancreas cancer receiving Gem + SBRT

SBRT With Gem

25 Gy single fraction dose using Trilogy linear accelerator

SBRT

Age, Categorical

Age, Continuous

Gender

United States

Region of Enrollment

Dr. Albert Koong

patients w/ pancreas Cancer receiving Stereotactic Radiosurgery and Gemcitabine

Stereotactic Radiosurgery

Rate of Local Control

single fraction 25 Gy dose Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine

Stereotactic Body Radiotherapy: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator

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

Median Overall Survival Time

patients that received a single fraction of 25 Gy Stereotactic Body Radiotherapy followed by weekly Gemcitabine administered at 1000mg/m2 over 100 minutes.

Patients will be followed at 4-6 weeks, 3 months, 6 months, 9 months and 1 year, in year 2 follow up will be every 4 months and in year 3 follow up will be every 6 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer	NCT00350142	Pancreatic Canc...	Stereotactic Bo... Gemcitabine 4D pancreatic p... FDG PET scan	18 Years - 90 Years	Stanford University
Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer	NCT00350142	Pancreatic Canc...	Stereotactic Bo... Gemcitabine 4D pancreatic p... FDG PET scan	18 Years - 90 Years	Stanford University

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