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

NCT01570998 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 117515NCI-2017-00461
• Study Type: interventional
• Target: 1,259
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Stage IA Breast Cancer; Stage IIA Breast Cancer

Outcome Measures

Primary Outcomes (5)

• Incidence of local recurrence

  Local tumor control is defined as no recurrent tumor in the ipsilateral breast. 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. The two patient cohorts will not be separated for the analysis regarding local control.

  Up to 5 years

• Frequency of site of relapse within the breast

  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 (IORT).

  Up to 5 years

• Percentage of participants with treatment-related adverse events

  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 hematoma, seroma, wound infection, wound breakdown and delayed wound healing will be assessed according to Radiation Therapy Oncology Group (RTOG) criteria. Late skin reactions, rash, telangiectasia and pain due to radiation and all other toxicities will be recorded and graded according to standard NCI-CTCAE V. 4 criteria

  Up to 5 years

• Median Relapse-free survival

  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. All patients will be analyzed under an "Intent to Treat" policy

  Up to 5 years

• Median Overall Survival

  Overall survival will be the time interval between enrollment and death.

  Up to 5 years

Study Arms (1)

Treatment (IORT)

EXPERIMENTAL

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

Radiation: Intraoperative Radiation Therapy; Other: Laboratory Biomarker Analysis

Interventions

Intraoperative Radiation Therapy RADIATION

Undergo IORT

Also known as: Intraoperative Radiotherapy, IORT, radiotherapy, intraoperative

Treatment (IORT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (IORT)

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Axillary lymph node positive breast 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
• Patients under the age of 50
• Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
• Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")
• Lymphovascular invasion
• High grade

Sponsors & Collaborators

• University of California, San Francisco: lead
• Carl Zeiss Meditec AG: collaborator

Study Sites (25)

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

University of California, Irvine

Irvine, California, 92617, United States

Location

Dignity Health - California Hospital Medical Center

Los Angeles, California, 90015, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

John Muir Medical Center-Walnut Creek

Walnut Creek, California, 94598, United States

Location

Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Cleveland Clinic

Fort Lauderdale, Florida, 33308, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Community Cancer Center South

Indianapolis, Indiana, 46227, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Marie Yeager Cancer Center, Spectrum Health Lakeland

Saint Joseph, Michigan, 49085, United States

Location

Community Hospital at Dobbs Ferry

Dobbs Ferry, New York, 10522, United States

Location

Cornell University

Ithaca, New York, 14850-2488, United States

Location

Columbia University/Herbert Irving Cancer Center

New York, New York, 10032, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania, 18045, United States

Location

Inova Fairfax Hospital Cancer Center

Fairfax, Virginia, 22031, United States

Location

Sentara Port Warwick

Newport News, Virginia, 23606, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Michael Alvarado, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: April 4, 2012
• Study Start: May 18, 2012
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)