Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer

Breast Cancer Clinical Trial

— EXIBT  

Official title:

Electronic Xoft Intersociety Brachytherapy Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742222
• Other study ID #: TPR-0186
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2008
• Last updated: May 16, 2016
• Start date: May 2008
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: Xoft, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patient 50 years of age or older

• Estrogen receptor positive

• Tumor size = 3cm

• Tumor histology: invasive carcinoma or DCIS

• Patient is node negative

• Patient has negative surgical margins (NSABP definition, no tumor on ink) after final surgery

• Life expectancy > 5 years

Exclusion Criteria:

• Pregnancy or breast-feeding. (If appropriate, patient must use birth control during the registry.) The need for a pregnancy test is based on the physician's standard practice and will be performed according to the physician's standard of care.

• Collagen Vascular Disease

• Scleroderma

• Systemic sclerosis

• Active lupus

• Infiltrating lobular histology

• Previous ipsilateral radiation to the thorax or breast

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ
• Lumpectomy

Intervention

Radiation:
• Electronic Brachytherapy
34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day.
• Intracavitary accelerated partial breast irradiation
3.4 Gy BID x 5 days

Locations

Country	Name	City	State
United States	Cancer Institute of Cape Girardeau	Cape Girardeau	Missouri
United States	Dallas Surgical Group / Northpoint Cancer Center	Dallas	Texas
United States	AtlantiCare Cancer Care Institute	Galloway	New Jersey
United States	Beverly Oncology	Montebello	California
United States	Nazha Cancer Center	Northfield	New Jersey
United States	Florida Radiation Oncology Group	Orange Park	Florida
United States	St Elizabeth's and Memorial Cancer Center	Swansea	Illinois
United States	DCH Cancer Treatment Center	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Xoft, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Dickler A, Kirk MC, Seif N, Griem K, Dowlatshahi K, Francescatti D, Abrams RA. A dosimetric comparison of MammoSite high-dose-rate brachytherapy and Xoft Axxent electronic brachytherapy. Brachytherapy. 2007 Apr-Jun;6(2):164-8. — View Citation

Smitt MC, Kirby R. Dose-volume characteristics of a 50-kV electronic brachytherapy source for intracavitary accelerated partial breast irradiation. Brachytherapy. 2007 Jul-Sep;6(3):207-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; six month, one year, two year, three year, four year, and five year.		5 years	No
Secondary	Local-regional Breast Failure - Ipsilateral breast failure at five years, Including: Ipsilateral recurrence within the initially treated volume, Ipsilateral recurrence of cancer outside of the initially treated volume, and axillary nodal recurrence		5 years	No