Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350142
Status:
COMPLETED
Last Update Posted:
2017-02-14
First Post:
2006-07-05
Brief Title:
Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer
Sponsor:
Albert Koong
Organization:
Stanford University
Study Overview
Official Title:
Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 TrilogyTM 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 999 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PANC0005 | OTHER | Stanford OnCore | None |