Intra-Operative Radiation Therapy Immediately Following Resection of Early Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02040493
Recruitment Status : Terminated
First Posted : January 20, 2014
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):
Xoft, Inc.

January 16, 2014
January 20, 2014
July 25, 2017
September 2008
October 4, 2016   (Final data collection date for primary outcome measure)
  • Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer. [ Time Frame: 5 Years ]
    Local recurrence will be assessed at one (1) month, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
  • Occurence of serious adverse events during and following IORT treatment. [ Time Frame: 5 Years ]

    Serious adverse events are defined as a serious injury or illness that:

    1. is life threatening, even if temporary in nature;
    2. results in permanent impairment of a body function or permanent damage to a body structure; or
    3. necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Same as current
Complete list of historical versions of study NCT02040493 on Archive Site
Cosmesis [ Time Frame: 5 Years ]
Cosmesis will be evaluated with the Harvard scale at one (1) month, six (6) months, and at one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
Same as current
Not Provided
Not Provided
Intra-Operative Radiation Therapy Immediately Following Resection of Early Stage Breast Cancer
Intra-Operative Radiation Therapy (IORT) Treatment Immediately Following Resection of Early Stage Breast Cancer
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.

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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Radiation: Intra-operative radiation therapy (IORT)
All subjects will receive IORT at the time of lumpectomy.
Experimental: Intra-operative radiation therapy (IORT)
Intervention: Radiation: Intra-operative radiation therapy (IORT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 4, 2016
October 4, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
45 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Xoft, Inc.
Xoft, Inc.
Not Provided
Principal Investigator: Adam Dickler, MD Little Company of Mary Hospital
Xoft, Inc.
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP