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

NCT ID: NCT00742222

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2015-01-31

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.

Conditions

Breast Cancer; Carcinoma; Lumpectomy; Ductal Carcinoma in Situ

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm, treatment with FDA cleared technology

Patients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study.

Group Type: OTHER

Electronic Brachytherapy

Intervention Type: RADIATION

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

Intervention Type: RADIATION

3.4 Gy BID x 5 days

Interventions

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.

Intervention Type: RADIATION

Intracavitary accelerated partial breast irradiation

3.4 Gy BID x 5 days

Intervention Type: RADIATION

Other Intervention Names

Radiation therapy; APBI; Intracavitary APBI; Accelerated partial breast irradiation; Xoft procedure; Partial breast irradiation; Partial breast radiation therapy; Balloon brachytherapy; Electronic source radiation therapy; Xoft Axxent system; electronic brachytherapy

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xoft, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Beitsch, MD

Role: PRINCIPAL_INVESTIGATOR

Dallas Surgical Group

Rakesh Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Radiation Oncology Department

Locations

DCH Cancer Treatment Center

Tuscaloosa, Alabama, United States

Beverly Oncology

Montebello, California, United States

Florida Radiation Oncology Group

Orange Park, Florida, United States

St Elizabeth's and Memorial Cancer Center

Swansea, Illinois, United States

Cancer Institute of Cape Girardeau

Cape Girardeau, Missouri, United States

AtlantiCare Cancer Care Institute

Galloway, New Jersey, United States

Nazha Cancer Center

Northfield, New Jersey, United States

Dallas Surgical Group / Northpoint Cancer Center

Dallas, Texas, United States

Countries

United States

References

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. doi: 10.1016/j.brachy.2007.01.005.

Reference Type: BACKGROUND

PMID: 17434111 (View on PubMed)

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. doi: 10.1016/j.brachy.2007.03.002.

Reference Type: BACKGROUND

PMID: 17681242 (View on PubMed)

Other Identifiers

TPR-0186

Identifier Type: -

Identifier Source: org_study_id