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

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

California

Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Approved
Contact: Christine S. Chung
Phone: 510-204-5311
Email: chungc1@sutterhealth.org
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Erin H. Lin
Email: erinhl@uci.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Michael David Alvarado
Phone: 415-353-7111
Walnut Creek
John Muir Medical Center-Walnut Creek
Status: Active
Contact: Marjaneh Moini
Phone: 925-947-3250
Email: marjaneh.moini_MD@johnmuirhealth.com

Connecticut

Greenwich
Greenwich Hospital
Status: Active
Contact: Daniela Gidea-Addeo
Phone: 203-863-3773
Email: Daniela.Addeo@greenwichhospital.org

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Contact: Shawna C. Willey
Phone: 202-444-0241
Email: scw9@gunet.georgetown.edu
MedStar Washington Hospital Center
Status: Active
Contact: Marc E. Boisvert
Phone: 202-877-7937
Email: marc.e.boisvert@medstar.net

Florida

Fort Lauderdale
Holy Cross Hospital
Status: In review
Contact: Joseph J. Casey
Phone: 954-772-6700
Email: joseph.casey@holy-cross.com

Georgia

Savannah
Memorial Health University Medical Center
Status: Active
Contact: Aaron Watson Pederson
Email: aaronpederson@memorialhealth.com

Illinois

Chicago
Northwestern University
Status: Active
Contact: Eric D. Donnelly
Phone: 312-926-4247
Email: edonnell@nmff.org
Maywood
Loyola University Medical Center
Status: Active
Contact: William Small
Phone: 708-216-2559
Email: wmsamll@lumc.edu

Indiana

Indianapolis
Community Cancer Center South
Status: Active
Contact: Susan Chace Lottich
Phone: 317-497-6922
Email: greatkarma2006@yahoo.com

Maryland

Baltimore
Mercy Medical Center
Status: Active
Contact: Neil Barry Friedman
Phone: 410-332-9330
Email: nfriedman@mdmercy.com

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Rebecca Chaohua Yang
Phone: 978-538-4039
Email: rebecca.c.yang@lahey.org

Michigan

Saint Joseph
Marie Yeager Cancer Center
Status: Active
Contact: Benjamin Thomas Gielda
Phone: 269-983-8888
Email: bgielda@lakelandhealth.org

New York

Dobbs Ferry
Community Hospital at Dobbs Ferry
Status: Active
Contact: Pond Remsen Kelemen
Phone: 914-693-5025
Email: prkelemen@hotmail.com
Ithaca
Cornell University
Status: In review
Contact: Mary Katherine Hayes
Phone: 212-746-3610
Email: mkh2001@med.cornell.edu
Poughkeepsie
Vassar Brothers Medical Center
Status: Active
Contact: Angela J. Keleher
Phone: 845-483-6500
Email: akeleher@health-quest.org

Pennsylvania

Easton
Saint Luke's Hospital-Anderson Campus
Status: Active
Contact: Lee B. Riley
Phone: 484-503-4105
Email: rileyl@slhn.org

Virginia

Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Stella Hetelekidis
Email: stella.hetelekidis@inova.org
Newport News
Sentara Port Warwick
Status: In review
Contact: Richard A Hoefer
Phone: 757-594-1806
Email: rahoefer@sentara.com

West Virginia

Morgantown
West Virginia University Healthcare
Status: Active
Contact: Geraldine M. Jacobson
Phone: 304-598-4706
Email: gmjacobson@hsc.wvu.edu

Wisconsin

Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: William Lewis Owens
Phone: 920-288-8480
Email: william.owens@aurora.org

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase IV

Trial Type

Treatment

Lead Organization

Lead Organization
UCSF Medical Center-Mount Zion

Principal Investigator
Michael David Alvarado

Trial IDs

Primary ID 117515
Secondary IDs NCI-2017-00461, 11-06843
Clinicaltrials.gov ID NCT01570998