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Summary

for females ages 45 years and up
at San Francisco, California and other locations
study started

Description

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.

Official Title

Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

Details

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.

Keywords

Stage IA Breast Cancer Stage IIA Breast Cancer

Eligibility

You can join if…

Open to females ages 45 years and up

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

You CAN'T join if...

  • 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

Locations

  • Alta Bates Summit Medical Center-Herrick Campus not yet accepting patients
    Berkeley, California, 94704, United States
  • John Muir Medical Center-Walnut Creek accepting new patients
    Walnut Creek, California, 94598, United States
  • California Hospital Medical Center not yet accepting patients
    Los Angeles, California, 90015, United States

Details

Status
accepting new patients
Start Date
Sponsor
University of California, San Francisco
ID
NCT01570998
Phase
Phase 4
Lead Scientist
Michael Alvarado
Study Type
Interventional
Last Updated
April 1, 2017
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