Intraoperative Radiation Therapy in Treating Patients with Breast Cancer Undergoing 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.
- Operable invasive breast cancer
- T1 and T2 (< 3.5 cm), N0, M0, confirmed by clinical, cytological or histological examination
- Suitable for breast conserving surgery and radiotherapy
- Ipsilateral diagnostic mammogram within 12 months of enrollment
- Axillary lymph node positive breast cancer (fine needle aspiration [FNA] not required)
- Invasive lobular cancer
- Tumor size > 3.5 cm
- 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
- 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 is 75% or greater
- Any factor included as exclusion criteria in the participating center’s treatment policy statement
Locations & Contacts
Contact: Christine S. Chung
Contact: Erin H. Lin
Contact: Michael David Alvarado
Contact: Marjaneh Moini
Contact: Daniela Gidea-Addeo
District of Columbia
Contact: Shawna C. Willey
Contact: Marc E. Boisvert
Status: In review
Contact: Joseph J. Casey
Contact: Aaron Watson Pederson
Contact: Eric D. Donnelly
Contact: William Small
Contact: Susan Chace Lottich
Contact: Neil Barry Friedman
Contact: Rebecca Chaohua Yang
Contact: Benjamin Thomas Gielda
Contact: Pond Remsen Kelemen
Status: In review
Contact: Mary Katherine Hayes
Contact: Angela J. Keleher
Contact: Lee B. Riley
Contact: Stella Hetelekidis
Status: In review
Contact: Richard A Hoefer
Contact: Geraldine M. Jacobson
Contact: William Lewis Owens
Trial Objectives and Outline
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.
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.
Trial Phase & Type
UCSF Medical Center-Mount Zion
Michael David Alvarado
Secondary IDs NCI-2017-00461, 11-06843
Clinicaltrials.gov ID NCT01570998