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Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by University of California, San Francisco
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01570998
First received: March 2, 2012
Last updated: April 28, 2017
Last verified: April 2017
March 2, 2012
April 28, 2017
May 2012
June 2017   (Final data collection date for primary outcome measure)
Incidence of local recurrence [ Time Frame: Up to 5 years ]
Statistical analysis of this study is primarily descriptive and exploratory. An "intent to treat" analysis will be conducted mainly using the log-rank test and Kaplan-Meier to compare hazard rates. Other parametric and nonparametric methods of analysis will also be used.
In-breast local failure and patterns of in-breast failure [ Time Frame: 1 month post-radiation therapy through year 5 ]
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.
Complete list of historical versions of study NCT01570998 on ClinicalTrials.gov Archive Site
Not Provided
  • Toxicity and morbidity [ Time Frame: 1 month post-radiation therapy through 5 years ]
    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 ]
    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 ]
    Overall survival will be the time interval between enrollment and death
Not Provided
Not Provided
 
Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery
This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.

PRIMARY OBJECTIVES:

I. To establish eligibility criteria based on previously published trials and studies in order to allow women who meet these criteria to receive intraoperative radiation therapy (IORT) on an Institutional Review Board (IRB)-approved protocol.

II. To systematically collect and assess acute and long-term toxicity and outcomes in larger cohort of patients.

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

IV. In-breast local failure and patterns of in-breast failure. V. Ipsilateral regional nodal failure. VI. Toxicity and morbidity. VII. Relapse-free survival. VIII. Overall survival.

OUTLINE:

Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.

After completion of study treatment, patients are followed up within 6 weeks and then every 6 months for 3 years and yearly for 2 years.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Stage IA Breast Cancer
  • Stage IIA Breast Cancer
  • Radiation: Intraoperative Radiation Therapy
    Undergo IORT
    Other Names:
    • Intraoperative Radiotherapy
    • IORT
    • radiotherapy, intraoperative
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Experimental: Treatment (IORT)
Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.
Interventions:
  • Radiation: Intraoperative Radiation Therapy
  • Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
Not Provided
June 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Suitable for breast conserving surgery
  • T1 and T2 (< 3.5 cm), N0, M0

Exclusion Criteria:

  • 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), as assessed on surgical pathologic lumpectomy specimen
  • Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
  • Inability to assess pathologic margin status
  • Synchronous 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 reducing tumor size
  • Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater
  • Any factor included as exclusion criteria in the participating center's treatment policy statement
  • Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):

    • Patients under the age of 50
    • Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
    • HER2 positive (as defined in Treatment Policy under "HER2")
    • Lymphovascular invasion
    • High grade
    • Tumors > 3 cm
    • Node positive patients
    • Prior chemotherapy or hormone therapy
Sexes Eligible for Study: Female
45 Years and older   (Adult, Senior)
No
United States
 
 
NCT01570998
117515
NCI-2017-00461 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
11-06843
117515 ( Other Identifier: UCSF Medical Center-Mount Zion )
P30CA082103 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Michael Alvarado UCSF Medical Center-Mount Zion
University of California, San Francisco
April 2017

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