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

NCT00742222 | Completed Phase 4 DMC

• 1 other identifier: TPR-0186
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 8

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:
• 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.
• 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
• TREATMENT DEVICE

Conditions

Breast Cancer; Carcinoma; Lumpectomy; Ductal Carcinoma in Situ

Keywords

Electronic brachytherapy registry; Multi-society registry; Breast cancer registry

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

single arm, treatment with FDA cleared technology

OTHER

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

Radiation: Electronic Brachytherapy; Radiation: Intracavitary accelerated partial breast irradiation

Interventions

Electronic Brachytherapy RADIATION

34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day.

Also known as: Radiation therapy, APBI, Intracavitary APBI, Accelerated partial breast irradiation, Xoft procedure, Partial breast irradiation, Partial breast radiation therapy, Balloon brachytherapy, Electronic source radiation therapy

single arm, treatment with FDA cleared technology

Intracavitary accelerated partial breast irradiation RADIATION

3.4 Gy BID x 5 days

Also known as: Xoft Axxent system, electronic brachytherapy

single arm, treatment with FDA cleared technology

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xoft, Inc.: lead

Study Sites (8)

DCH Cancer Treatment Center

Tuscaloosa, Alabama, 35401, United States

Location

Beverly Oncology

Montebello, California, 90640, United States

Location

Florida Radiation Oncology Group

Orange Park, Florida, 32073, United States

Location

St Elizabeth's and Memorial Cancer Center

Swansea, Illinois, 62226, United States

Location

Cancer Institute of Cape Girardeau

Cape Girardeau, Missouri, 63703, United States

Location

AtlantiCare Cancer Care Institute

Galloway, New Jersey, 08205, United States

Location

Nazha Cancer Center

Northfield, New Jersey, 08225, United States

Location

Dallas Surgical Group / Northpoint Cancer Center

Dallas, Texas, 75230, United States

Location

Related 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. doi: 10.1016/j.brachy.2007.01.005.

  PMID: 17434111 BACKGROUND

• 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.

  PMID: 17681242 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma; Carcinoma, Intraductal, Noninfiltrating

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Peter Beitsch, MD

  Dallas Surgical Group

  PRINCIPAL INVESTIGATOR

• Rakesh Patel, MD

  University of Wisconsin Radiation Oncology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 27, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2015-07

Locations

US (8)