Ignite Creation Date:
2025-12-18 @ 9:58 AM
Ignite Modification Date:
2025-12-18 @ 9:58 AM
Study NCT ID:
NCT00742222
Status:
None
Last Update Posted:
2016-05-17 00:00:00
First Post:
2008-08-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
Electronic Xoft Intersociety Brachytherapy Trial
Status:
None
Status Verified Date:
2015-07
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:
EXIBT
Brief Summary:
PRINCIPAL INVESTIGATORS
* Rakesh Patel, MD- Radiation Oncologist
* Peter Beitsch, MD- Breast Surgeon
REGISTRY DESIGN
* Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients.
SAMPLE SIZE AND SITES:
* Approximately 400 patients may be enrolled.
* Up to 100 qualified U.S. sites may participate in this registry.
ENDPOINTS:
1. PRIMARY ENDPOINTS
* Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; at six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
* Skin Toxicities - Specific toxicities that can result from radiation therapy will be recorded at each follow-up visit. The Common Terminology Criteria for Adverse Events will be used and to be recorded at each follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
* Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and graded in two ways:
* Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will be completed at the following visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
2. SECONDARY ENDPOINTS
* Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years.
This includes:
* Ipsilateral recurrence within the initially treated volume. (Within the tumor bed)
* Ipsilateral recurrence of cancer outside of the initially treated volume. (Elsewhere Failure)
* Axillary nodal recurrence
* Survival - to be recorded at each follow-up visit
* Overall Survival
* Disease Free Survival
* Device Performance - to be recorded during the balloon applicator placement and during the course of the radiation treatments:
* Ability to deliver treatment
* Axxent System / Balloon Applicator performance
3. TREATMENT DEVICE
The device to be used is the electronic brachytherapy system for the treatment of early stage breast cancer with intracavitary accelerated partial breast irradiation. The device manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment of early stage breast cancer can be used in this post market data collection registry.
OVERSIGHT COMMITTEE
Representatives from American Brachytherapy Society (ABS), American Society of Breast Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study management.
* Rakesh Patel, MD- Radiation Oncologist
* Peter Beitsch, MD- Breast Surgeon
REGISTRY DESIGN
* Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients.
SAMPLE SIZE AND SITES:
* Approximately 400 patients may be enrolled.
* Up to 100 qualified U.S. sites may participate in this registry.
ENDPOINTS:
1. PRIMARY ENDPOINTS
* Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; at six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
* Skin Toxicities - Specific toxicities that can result from radiation therapy will be recorded at each follow-up visit. The Common Terminology Criteria for Adverse Events will be used and to be recorded at each follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
* Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and graded in two ways:
* Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will be completed at the following visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
2. SECONDARY ENDPOINTS
* Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years.
This includes:
* Ipsilateral recurrence within the initially treated volume. (Within the tumor bed)
* Ipsilateral recurrence of cancer outside of the initially treated volume. (Elsewhere Failure)
* Axillary nodal recurrence
* Survival - to be recorded at each follow-up visit
* Overall Survival
* Disease Free Survival
* Device Performance - to be recorded during the balloon applicator placement and during the course of the radiation treatments:
* Ability to deliver treatment
* Axxent System / Balloon Applicator performance
3. TREATMENT DEVICE
The device to be used is the electronic brachytherapy system for the treatment of early stage breast cancer with intracavitary accelerated partial breast irradiation. The device manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment of early stage breast cancer can be used in this post market data collection registry.
OVERSIGHT COMMITTEE
Representatives from American Brachytherapy Society (ABS), American Society of Breast Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study management.
Detailed Description:
None
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?: