Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165126
Status:
COMPLETED
Last Update Posted:
2009-11-01
First Post:
2005-09-09
Brief Title:
Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-10
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:
The purpose of this study is to investigate the effect of certain variables such as the fullness of the patients bladder and the position of the treatment applicator on the dose of radiation that other organs such as the bladder and the rectum receive during radiation treatment for endometrial carcinoma
Detailed Description:
This study is separated into 2 phases In phase 1 patients will be asked to have their bladder full for the second planned insertion of the brachytherapy applicator and empty for the third insertion For phase 2 the effect of cylinder angle on normal tissue dosimetry will be investigated Of the two bladder states assessed in phase 1 empty or full the one deemed to give the lower dose to the total amount of bladder tissue will be considered the standard and applied to all patients in phase 2
In phase 1 to standardize bladder filling patients will be asked to empty their bladder then to drink 32 oz of water one and a half hours before the CT scan The patient will undergo a treatment-planning scan after the brachytherapy cylinder is inserted and before brachytherapy treatment
In phase 2 patients will be asked to fill or empty their bladder according to the results of phase 1 The vaginal cylinder will be placed horizontally for the second treatment The cylinder will then be angled at a specific angle for the subsequent treatment
A history and physical exam will be performed within 2 weeks of study entry then at 14 days 90 days and 180 days following the completion of therapy
In phase 1 to standardize bladder filling patients will be asked to empty their bladder then to drink 32 oz of water one and a half hours before the CT scan The patient will undergo a treatment-planning scan after the brachytherapy cylinder is inserted and before brachytherapy treatment
In phase 2 patients will be asked to fill or empty their bladder according to the results of phase 1 The vaginal cylinder will be placed horizontally for the second treatment The cylinder will then be angled at a specific angle for the subsequent treatment
A history and physical exam will be performed within 2 weeks of study entry then at 14 days 90 days and 180 days following the completion of therapy
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