Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386919
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2006-10-11
Brief Title:
Short Course of Radiation for Gliomas in Elderly Patients
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
A Phase II Study of Hypofractionated Radiation With CyberKnife Stereotactic Radiosurgery Boost for High Grade Gliomas in Elderly Patients With Good Performance Status
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Patients with high grade brain tumors will be treated to test shortened course of radiation therapy with the use of precise focused radiation with cyberknife
Detailed Description:
Screening Procedures Screening procedures are tests and procedures that will be done to determine if you are eligible to take part in the research study For this research study the screening procedures include Medical history physical examination including neurological and performance status assessment of preoperative and postoperative scans operative reports and pathology reports All of these have already been performed or will be performed as standard of care for your condition even if you are not taking part in this study
Research Procedures If you qualify to take part in this research study you will undergo these research procedures The pre- and post operative MRI Magnetic Resonance Imaging scans before and after your operation the operative procedure including sampling known as biopsy or removal of as much as tumor as possible and the procedures to facilitate radiation therapy planning making a mask in the treatment position to keep you comfortably still and CAT scan in the treatment position These are all part of standard procedures in the treatment of your tumor whether you are in this study or not
One of the primary reasons to deliver radiation in multiple small doses conventionally 30-33 treatments over 6-612 weeks is to minimize damage to the surrounding normal brain The Cyberknife technology allows precise delivery of radiation to your tumor while minimizing radiation to the surrounding brain This allows the possibility of delivering higher doses of radiation to the tumor thereby shortening the overall treatment time 18 treatments in 312 weeks This is what is being studied in this study
The Cyberknife treatment will be longer in duration lasting about 30-60 minutes rather than 5-10 minutes with each conventional radiation treatment During this time you will be asked to lie as comfortably still as you can The technology however permits the radiation beam to adjust precisely to any small movements you may make to maintain the accuracy
Along with radiation you will get chemotherapy called Temozolomide in the form of pills This is also standard treatment whether or not you are in this study You will be asked to take these pills every day during the course of radiation and for 5 days each month thereafter for a year However during radiation you will be receiving Temozolomide which is used to possibly make the radiation more effective only for 4 weeks as opposed to 6 weeks of conventional radiation As part of usual care with this chemotherapy you may receive supportive medication to prevent and treat nausea vomiting low blood counts or infection
MonitoringFollow-Up Procedures Procedures performed to evaluate the effectiveness and safety of the experimental procedures are called monitoring or follow-up procedures For this research study the monitoringfollow-up procedures include Clinical assessment including neurological and performance status assessments and blood tests for your chemotherapy will be performed every month for the first year and every three months thereafter MRI scans one month after completion of radiation therapy and every 2 months thereafter All these procedures are performed routinely in the management of your tumor
Research Procedures If you qualify to take part in this research study you will undergo these research procedures The pre- and post operative MRI Magnetic Resonance Imaging scans before and after your operation the operative procedure including sampling known as biopsy or removal of as much as tumor as possible and the procedures to facilitate radiation therapy planning making a mask in the treatment position to keep you comfortably still and CAT scan in the treatment position These are all part of standard procedures in the treatment of your tumor whether you are in this study or not
One of the primary reasons to deliver radiation in multiple small doses conventionally 30-33 treatments over 6-612 weeks is to minimize damage to the surrounding normal brain The Cyberknife technology allows precise delivery of radiation to your tumor while minimizing radiation to the surrounding brain This allows the possibility of delivering higher doses of radiation to the tumor thereby shortening the overall treatment time 18 treatments in 312 weeks This is what is being studied in this study
The Cyberknife treatment will be longer in duration lasting about 30-60 minutes rather than 5-10 minutes with each conventional radiation treatment During this time you will be asked to lie as comfortably still as you can The technology however permits the radiation beam to adjust precisely to any small movements you may make to maintain the accuracy
Along with radiation you will get chemotherapy called Temozolomide in the form of pills This is also standard treatment whether or not you are in this study You will be asked to take these pills every day during the course of radiation and for 5 days each month thereafter for a year However during radiation you will be receiving Temozolomide which is used to possibly make the radiation more effective only for 4 weeks as opposed to 6 weeks of conventional radiation As part of usual care with this chemotherapy you may receive supportive medication to prevent and treat nausea vomiting low blood counts or infection
MonitoringFollow-Up Procedures Procedures performed to evaluate the effectiveness and safety of the experimental procedures are called monitoring or follow-up procedures For this research study the monitoringfollow-up procedures include Clinical assessment including neurological and performance status assessments and blood tests for your chemotherapy will be performed every month for the first year and every three months thereafter MRI scans one month after completion of radiation therapy and every 2 months thereafter All these procedures are performed routinely in the management of your tumor
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