Targeted Intraoperative Radiotherapy United States (TARGIT-US) Registry Trial

This study is currently recruiting participants.
Verified January 2014 by University of California, San Francisco
Sponsor:
Collaborators:
H. Lee Moffitt Cancer Center and Research Institute
Northwestern University
Los Angeles Center for Women's Health
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01570998
First received: March 2, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

This study proposes to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single dose after breast conserving surgery, with or without whole breast radiation as indicated by pathologic risk factors, in women with early stage breast cancer.


Condition Intervention Phase
Malignant Neoplasm of Breast
Breast Diseases
Ductal Breast Carcinoma
Radiation: Intraoperative radiation therapy (IORT)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • In-breast local failure and patterns of in-breast failure [ Time Frame: 1 month post-radiation therapy through year 5 ] [ Designated as safety issue: No ]
    Patients will be regularly monitored as per the individual center's policy provided this meets the minimum trial criteria for follow-up with physical examination at least every 6 months for 3 years and yearly at 4 and 5 years post-treatment. Confirmation of recurrence will follow clinical examination and cytology or biopsy. Site of relapse within the breast will be recorded in order to assess whether the recurrence is at the site of initial tumor or at a new site and whether it has occurred within the treated field.


Secondary Outcome Measures:
  • Toxicity and morbidity [ Time Frame: 1 month post-radiation therapy through 5 years ] [ Designated as safety issue: Yes ]
    Local toxicity and morbidity will be recorded as adverse events related to the primary treatment of the breast cancer. These were recorded in the randomized trial and outcomes showed no significant difference in clinical complications for the IORT as compared to standard external beam radiation. However all expected toxicities of acute skin reaction, wound infection, wound breakdown, late skin reactions, and pain due to radiation will be graded according to RTOG criteria. All other toxicities will be recorded and graded according to standard NCI-CTCAE V. 4 criteria.

  • Relapse-free survival [ Time Frame: 1 month post-radiation therapy through 5 years ] [ Designated as safety issue: Yes ]
    Relapse-free survival will be recorded as the time interval between trial entry and the date of confirmation of any recurrence. The actual date to be used is the clinic day on which the investigations that led to a confirmed diagnosis of the recurrence were requested. Relapse-free survival would include any recurrence of breast cancer (local,regional or distant) or death without prior report a relapse.

  • Overall survival [ Time Frame: 1 month post-radiation therapy through 5 years ] [ Designated as safety issue: Yes ]
    Overall survival will be the time interval between enrollment and death


Estimated Enrollment: 755
Study Start Date: May 2012
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraoperative radiation therapy (IORT)
The Intrabeam® Photon Radiosurgery System is a miniature electron beam-driven X-ray source which provides a point source of low energy X-rays (50 kV maximum) at the tip of a 3.2 mm diameter tube. The radiation source can be inserted into the area of interest immediately after excision of the tumor and switched on for 20-35 minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and early clinical applications of this device have been well studied and this is the device which was utilized in the international TARGIT trial.
Radiation: Intraoperative radiation therapy (IORT)
The Intrabeam® Photon Radiosurgery System is a miniature electron beam-driven X-ray source which provides a point source of low energy X-rays (50 kV maximum) at the tip of a 3.2 mm diameter tube. The radiation source can be inserted into the area of interest immediately after excision of the tumor and switched on for 20-35 minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and early clinical applications of this device have been well studied and this is the device which was utilized in the international TARGIT trial.The Intrabeam is FDA approved for use in any part of the body. For breast irradiation, the radiation source is covered by a spherical applicator that is used to uniformly conform the lumpectomy cavity around the radiation source, enabling delivery of an accurately calculated dose to a prescribe depth.
Other Names:
  • intraoperative radiotherapy
  • Zeiss Intrabeam

Detailed Description:

A pragmatic registry trial has been designed and modeled after the original successful, international TARGIT-A protocol, to continue the use of intraoperative radiotherapy for a select population of women, and to follow outcomes with regards to local and regional control, toxicity and morbidity. Within this pragmatic single arm registry trial is a more selective approach that may be employed in some centers for some or all patients. Patients selected for breast conserving surgery who are considered to have a low risk of local recurrence are eligible for the registry trial once given their informed consent.

  Eligibility

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

Inclusion Criteria:

  • All patients aged 45 years or older with operable invasive breast cancer, T1 and T2 (< 3.5 cm), N0-1, M0, confirmed by cytological or histological examination, who are suitable for breast conserving surgery are eligible as long as they have had an ipsilateral diagnostic mammogram within 12 months of enrollment.
  • Those with previously diagnosed and treated contralateral breast cancer may be entered.
  • It is recommended that patients meet an ECOG performance status of 0-3, however, grade 4 patients can be treated at the discretion of the participating center.
  • Individual centers may wish to restrict entry to a more exactly defined subset of patients in which case only patients with these characteristics may be entered by the particular center. For example, centers may decide at outset to recruit only women over the age of 50 or possibly only postmenopausal women. Before entering any patient into the trial, the local investigator should confirm that the patient would be available for regular follow-up for at least 5 years.

Exclusion Criteria:

  • Age < 45 years
  • Axillary lymph node positive breast cancer
  • Invasive lobular cancer
  • Tumor size > 3.5 cm
  • Extensive Intraductal Component (EIC= > 25% of the lumpectomy specimen involved with ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen
  • Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound. MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy.
  • Inability to assess pathologic margin status
  • Bilateral breast cancer at the time of diagnosis.
  • Ipsilateral breast had a previous cancer and/or prior in-field radiation.
  • Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required).
  • Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumor size.
  • No more than 30 days can have elapsed between the last breast cancer surgery (not axillary) and entry into the trial for patients in the post-pathology stratification.
  • Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 75% or greater
  • Any factor included as exclusion criteria in the participating center's Treatment Policy Statement.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570998

Contacts
Contact: Janis Rice (415) 353-7408 janis.rice@ucsfmedctr.org

Locations
United States, California
Los Angeles Women's Health Clinic of California Hospital Medical Center Not yet recruiting
Los Angeles, California, United States, 90015
Principal Investigator: Dennis R Holmes, MD         
UCSF Carol Franc Buck Breast Care Center Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Michael D Alvarado, MD         
John Muir Medical Center Not yet recruiting
Walnut Creek, California, United States, 94598
Contact: Marjaneh Moini, MD         
Principal Investigator: Marjaneh Moini, MD         
United States, District of Columbia
MedStar Georgetown University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Shawna Wiley, MD         
Principal Investigator: Shawna Wiley, MD         
MedStar Washington Hospital Center Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Marc Boisvert, MD         
Principal Investigator: Marc Boisvert, MD         
United States, Illinois
Northwestern Memorial Hospital Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Eric Donnelly, MD         
Principal Investigator: Eric Donnelly, MD         
Loyola University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60153
Contact: William Small, MD         
Principal Investigator: William Small, MD         
United States, Maryland
Mercy Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21202
Contact: Neil Friedman, MD         
Principal Investigator: Neil Friedman, MD         
United States, Nebraska
Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68105
Contact: James Edney, MD         
Principal Investigator: James Edney, MD         
United States, New York
St. John's Riverside Health Hospital - Ashikari Breast Center, Dobbs Ferry Not yet recruiting
Dobbs Ferry, New York, United States, 10522
Contact: Pond Kelemen, MD         
Principal Investigator: Pond Kelemen, MD         
Weill Cornell Medical Center Not yet recruiting
New York, New York, United States, 10065
Principal Investigator: Mary Kay Hayes, MD         
Vassar Brothers Medical Center Not yet recruiting
Poughkeepsie, New York, United States, 12601
Contact: Angela Keleher, MD         
Principal Investigator: Angela Keleher, MD         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Stephanie Valente, MD         
Principal Investigator: Stephanie Valente, MD         
United States, Pennsylvania
St. Luke's Hospital and Health Network Not yet recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Lee Riley, MD         
Principal Investigator: Lee Riley, MD         
United States, Virginia
Sentara Medical Group Recruiting
Hampton, Virginia, United States, 23666
Contact: Richard Hoefer, MD         
Principal Investigator: Richard Hoefer, MD         
Sponsors and Collaborators
University of California, San Francisco
H. Lee Moffitt Cancer Center and Research Institute
Northwestern University
Los Angeles Center for Women's Health
Investigators
Principal Investigator: Michael D Alvarado, MD UCSF Carol Franc Buck Breast Care, Department of Surgery
Study Chair: Eleanor Harris, MD H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: William Small, MD Loyola University
Principal Investigator: Dennis R Holmes, MD Los Angeles Center for Women's Health
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01570998     History of Changes
Other Study ID Numbers: 117515
Study First Received: March 2, 2012
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Disease-Free Survival
Female
Humans
Intraoperative Care
Mastectomy Segmental
Middle Aged
Neoplasm Recurrence Local
Radiotherapy Dosage
Radiotherapy Adjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Carcinoma
Carcinoma, Ductal, Breast
Neoplasms by Site
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on April 17, 2014