Ignite Creation Date:
2024-05-05 @ 11:52 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01434550
Status:
WITHDRAWN
Last Update Posted:
2017-02-23
First Post:
2011-09-13
Brief Title:
Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Study of First-line Stereotactic Body Radiation Therapy SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer
Status:
WITHDRAWN
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
research cancelled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects good andor bad this treatment will have on participants and their cancer
Detailed Description:
The standard treatment for cancer of the pancreas is surgery if possible external beam radiation therapy andor chemotherapy These standard treatments are not a cure and often extend life by just a few months Recently a new approach has been developed called stereotactic body radiation therapy SBRT Based on the results of earlier studies using SBRT the study doctors at Moffitt feel this is a reasonable alternative to the standard treatment for your disease
Stereotactic body radiation therapy SBRT delivers high radiation doses to the tumor every day for 5 days which gives the usual 5-6 week course of radiation in less than a week It has also been shown to have much less side effects
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects good andor bad this treatment will have on you and your cancer
Six patients will be asked to be part of a subgroup called TBRI Tissue Blood Research Imaging In this subgroup the investigators want to study if there is early death of tumor cells from the treatment by looking at the tumor using PETCT scans and biopsies and by testing your bodys white blood cells taken by a procedure called leukapheresis You do not have to take part in the TBRI subgroup to get treatment on this study with SBRT
Stereotactic body radiation therapy SBRT delivers high radiation doses to the tumor every day for 5 days which gives the usual 5-6 week course of radiation in less than a week It has also been shown to have much less side effects
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects good andor bad this treatment will have on you and your cancer
Six patients will be asked to be part of a subgroup called TBRI Tissue Blood Research Imaging In this subgroup the investigators want to study if there is early death of tumor cells from the treatment by looking at the tumor using PETCT scans and biopsies and by testing your bodys white blood cells taken by a procedure called leukapheresis You do not have to take part in the TBRI subgroup to get treatment on this study with SBRT
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