Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165581
Status:
TERMINATED
Last Update Posted:
2007-12-21
First Post:
2005-09-13
Brief Title:
High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Breast Carcinoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Pilot Clinical Trial to Evaluate High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Favorable Stage I and II Breast Cancer
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to continuing review
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 understand the side effects skin reaction infection and abscess formation at the site of radiation treatment which my occur during the treatment and following 2 months using a new method of radiation therapy for breast cancer
Detailed Description:
Radiation treatment will be delivered in an outpatient setting twice a day in 5 consecutive treatment days There will be a minimum 6-hour interval between the two daily treatments The applicator is a simple tube with an inflatable balloon at one end a channel in the middle of the tube for treatment and two adapters at the other end
Following surgical removal of the breast cancer the radiation oncologist with the assistance of the surgeon or radiologist will place the applicator in the surgical cavity A small radioactive source iridium-192 will be inserted into the applicator by a special machine and after the final treatment the applicator will be removed
The following procedures will be done while the patient is on radiation therapy post-partial mastectomy mammogram of micro-calcifications to confirm complete removal CT scans for radiation treatment planning monitoring of the skin for side effects photographs of the breasts prior to the surgery prior to placement of the applicator and at 60 days after radiation treatment to evaluate the cosmetic outcome of the treatment
Participation in this study will last approximately 2 months after completion of radiation treatment
Following surgical removal of the breast cancer the radiation oncologist with the assistance of the surgeon or radiologist will place the applicator in the surgical cavity A small radioactive source iridium-192 will be inserted into the applicator by a special machine and after the final treatment the applicator will be removed
The following procedures will be done while the patient is on radiation therapy post-partial mastectomy mammogram of micro-calcifications to confirm complete removal CT scans for radiation treatment planning monitoring of the skin for side effects photographs of the breasts prior to the surgery prior to placement of the applicator and at 60 days after radiation treatment to evaluate the cosmetic outcome of the treatment
Participation in this study will last approximately 2 months after completion of radiation treatment
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