Trilogy Stereotactic Body Radiotherapy For Pancreatic Cancer

Study Overview

Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

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.

Pancreatic Cancer

RADIATION: Stereotactic Body Radiotherapy
DRUG: Gemcitabine
OTHER: 4D pancreatic protocol CT scan
RADIATION: FDG PET scan

PANC0005
PANC0005 (OTHER Identifier) (OTHER: Stanford OnCore)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-07-05	Results First Submitted 2013-12-06	Last Update Submitted that met QC Criteria 2016-12-26
First Submitted that Met QC Criteria 2006-07-05	Results First Submitted that Met QC Criteria 2014-08-06	Last Update Posted (ACTUAL) 2017-02-14
First Posted (ACTUAL) 2006-07-10	Results First Posted 2014-08-22	Last Verified 2016-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 Bo	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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 Bo

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.

Primary Outcome Measures	Measure Description	Time Frame
Rate of Local Control	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.	up to 3 years

Secondary Outcome Measures	Measure Description	Time Frame
Median Overall Survival Time	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.	up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Albert Koong, Stanford University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record