Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment intra-operative radiation therapy (iort)
Sponsor Xoft, Inc.
Start date September 2008
End date January 2017
Trial size 75 participants
Trial identifier NCT02040493, LCMH-001

Summary

This is a physician sponsored multi-center, non-randomized, prospectively enrolling data collection study of patients with early stage breast cancer treated with electronic brachytherapy at the time of surgical resection of the cancer in the operating room. The radiation therapy treatments will be administered with electronic brachytherapy using the FDA cleared Xoft Axxent System.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
IORT
intra-operative radiation therapy (iort)
All subjects will receive IORT at the time of lumpectomy.

Primary Outcomes

Measure
Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer.
time frame: 5 Years
Occurence of serious adverse events during and following IORT treatment.
time frame: 5 Years

Secondary Outcomes

Measure
Cosmesis
time frame: 5 Years

Eligibility Criteria

Female participants at least 45 years old.

General Inclusion Criteria 1. Age > 45 years 2. Tumor with Tis, T1, T2 (≤ 3cm), N0, M0 - (AJC Classification) 3. Invasive ductal carcinoma and / or DCIS Intra-operative Inclusion Criteria 1. Negative sentinel node assessment 2. Balloon surface to skin distance of at least 1-cm and adequate conformance via Intra-operative ultrasound Post procedure Inclusion Criteria 1. Negative microscopic surgical margins** **If positive margins patient my undergo re-excision and/or additional radiation at the treating physician's discretion but the patient will be excluded from the protocol data analysis. General Exclusion Criteria 1. Scleroderma, systemic sclerosis and active lupus 2. Participation in an investigational drug or device study 3. Previous ipsilateral radiation to the thorax or breast Intra-operative Exclusion Criteria 1. Intra-operative positive sentinel lymph node biopsy 2. Inadequate conformance (greater than 10% of PTV encompassed by fluid or air on physician assessment of intraOp ultrasound image) 3. Skin spacing less than 1-cm via intraOp ultrasound. 4. A cavity size that is not appropriate for a 40 -70 cc balloon. 5. Patient becomes unstable and physician determines patient is not a good candidate at time of lumpectomy.

Additional Information

Official title Intra-Operative Radiation Therapy (IORT) Treatment Immediately Following Resection of Early Stage Breast Cancer
Principal investigator Adam Dickler, MD
Description Breast Conserving Therapy (BCT) is a standard treatment option for patients with stage I or II breast cancer. Breast conserving therapy consists of surgical removal of the tumor with negative margins, axillary lymph node dissection or sentinel node biopsy and radiation therapy. Several studies have shown BCT to be comparable to mastectomy in terms of overall and disease free survival for patients. The major advantage to BCT over mastectomy is breast preservation and reduced psychological trauma to the patient. The major disadvantage to BCT is prolonged time of treatment. The whole breast radiation portion of BCT can add 7 weeks to the treatment time. This additional treatment time can be a detriment to women who logistically may not be able to meet the demands of daily irradiation for 6-7 weeks. A new form of treatment, breast brachytherapy, was developed to decrease the treatment time required for breast irradiation. This treatment uses the Xoft Axxent system to administer intra-operative breast brachytherapy in one treatment, at the time of lumpectomy in the operating room. This study has been designed to assess local recurrence, serious adverse events, adverse events and their severity, and cosmesis following intra-operative radiation therapy (IORT) using the Xoft Axxent System and balloon applicators. The study device is FDA cleared. The purpose of this clinical study is to compile data on the treatment of patients using the Xoft Axxent System for the delivery of radiation therapy in the intra-operative setting as part of breast conserving therapy in women with resected, early stage breast cancer.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Xoft, Inc..