Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00350142|
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : August 22, 2014
Last Update Posted : February 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Stereotactic Body Radiotherapy Drug: Gemcitabine Other: 4D pancreatic protocol CT scan Radiation: FDG PET scan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer|
|Study Start Date :||April 2006|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
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 RadiotherapyDrug: Gemcitabine
Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes
Other Name: GemzarOther: 4D pancreatic protocol CT scan
Patients will undergo this imaging procedure prior to treatment for planning purposes.
Other Name: computerized tomography scanRadiation: 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350142
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Albert Koong||Stanford University|