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

March 2, 2012
January 30, 2014
May 2012
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01570998 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Targeted Intraoperative Radiotherapy United States (TARGIT-US) Registry Trial
Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malignant Neoplasm of Breast
  • Breast Diseases
  • Ductal Breast Carcinoma
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
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.
Intervention: Radiation: Intraoperative radiation therapy (IORT)
Vaidya JS, Joseph DJ, Tobias JS, Bulsara M, Wenz F, Saunders C, Alvarado M, Flyger HL, Massarut S, Eiermann W, Keshtgar M, Dewar J, Kraus-Tiefenbacher U, Sütterlin M, Esserman L, Holtveg HM, Roncadin M, Pigorsch S, Metaxas M, Falzon M, Matthews A, Corica T, Williams NR, Baum M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet. 2010 Jul 10;376(9735):91-102. doi: 10.1016/S0140-6736(10)60837-9. Erratum in: Lancet. 2010 Jul 10;376(9735):90.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
755
Not Provided
January 2015   (final data collection date for primary outcome measure)

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.
Female
45 Years and older
No
Contact: Janis Rice (415) 353-7408 janis.rice@ucsfmedctr.org
United States
 
NCT01570998
117515
Yes
University of California, San Francisco
University of California, San Francisco
  • H. Lee Moffitt Cancer Center and Research Institute
  • Northwestern University
  • Los Angeles Center for Women's Health
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
University of California, San Francisco
January 2014

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