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Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350142
First Posted: July 10, 2006
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Albert Koong, Stanford University
  Purpose
This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine

Condition Intervention Phase
Pancreatic Cancer Radiation: Stereotactic Body Radiotherapy Drug: Gemcitabine Other: 4D pancreatic protocol CT scan Radiation: FDG PET scan Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Albert Koong, Stanford University:

Primary Outcome Measures:
  • Rate of Local Control [ Time Frame: up to 3 years ]

    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.



Secondary Outcome Measures:
  • Median Overall Survival Time [ Time Frame: up to 3 years ]
    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.


Enrollment: 20
Study Start Date: April 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.
Radiation: Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator
Other Name: single fraction 25 Gy dose Stereotactic Body Radiotherapy
Drug: Gemcitabine
Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes
Other Name: Gemzar
Other: 4D pancreatic protocol CT scan
Patients will undergo this imaging procedure prior to treatment for planning purposes.
Other Name: computerized tomography scan
Radiation: FDG PET scan
Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.
Other Name: Fluorodeoxyglucose (FDG)-positron emission tomography

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350142


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Albert Koong
Investigators
Principal Investigator: Albert Koong Stanford University
  More Information

Responsible Party: Albert Koong, Associate Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT00350142     History of Changes
Other Study ID Numbers: PANC0005
PANC0005 ( Other Identifier: Stanford OnCore )
First Submitted: July 5, 2006
First Posted: July 10, 2006
Results First Submitted: December 6, 2013
Results First Posted: August 22, 2014
Last Update Posted: February 14, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Albert Koong, Stanford University:
Stereotactic Body Radiotherapy (SBRT)
pancreas cancer
locally advanced
local control
Gemcitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs