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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xoft, Inc.
ClinicalTrials.gov Identifier:
NCT02040493
First received: January 16, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Radiation: Intra-operative radiation therapy (IORT)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-Operative Radiation Therapy (IORT) Treatment Immediately Following Resection of Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Xoft, Inc.:

Primary Outcome Measures:
  • Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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.


Secondary Outcome Measures:
  • Cosmesis [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: September 2008
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-operative radiation therapy (IORT)
IORT
Radiation: Intra-operative radiation therapy (IORT)
All subjects will receive IORT at the time of lumpectomy.

Detailed 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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02040493

Locations
United States, Arizona
Cancer Treatment Services Arizona
Casa Grande, Arizona, United States, 85122
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Diablo Valley Oncology Hematology
Pleasant Hill, California, United States, 94523
United States, Florida
University South Florida
Tampa, Florida, United States, 33612
United States, Illinois
Little Company of Mary Hospital
Evergreen Park, Illinois, United States, 60805
Rockford Memorial Hospital
Rockford, Illinois, United States, 61103
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 39213
United States, New Hampshire
Exeter Hospital
Exeter, New Hampshire, United States, 03833
United States, Tennessee
Parkridge
Chattanooga, Tennessee, United States, 37404
Sponsors and Collaborators
Xoft, Inc.
  More Information

No publications provided

Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT02040493     History of Changes
Other Study ID Numbers: LCMH-001
Study First Received: January 16, 2014
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Xoft, Inc.:
breast cancer
IORT
brachytherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 29, 2014