Single Dose Partial Breast Radiotherapy (RSU)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00944528
First received: July 22, 2009
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.


Condition Intervention Phase
Breast Cancer
Radiation: Radiosurgery
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    As measured by the incidence of acute toxicity and wound healing complications


Secondary Outcome Measures:
  • Local control [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
  • Cosmetic outcome [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
  • Magnetic Resonance Images(MRI) [ Time Frame: Pre and post SRS radiosurgery ] [ Designated as safety issue: No ]
    Pre and post-radiotherapy for exploratory analysis of radiation response.

  • Acquire tissue [ Time Frame: Pre and post SRS radiosurgery ] [ Designated as safety issue: No ]
    Pre and post-radiotherapy for exploratory analysis of radiation response


Estimated Enrollment: 32
Study Start Date: January 2010
Estimated Study Completion Date: May 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single dose radiosurgery: Dose Level 1
A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiation: Radiosurgery
Single dose or radiation in 15Gy, 18Gy or 21Gy
Other Names:
  • Radiosurgery
  • External beam radiation therapy
Experimental: Single dose radiosurgery: Dose Level 2
A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiation: Radiosurgery
Single dose or radiation in 15Gy, 18Gy or 21Gy
Other Names:
  • Radiosurgery
  • External beam radiation therapy
Experimental: Single dose radiosurgery: Dose Level 3
A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
Radiation: Radiosurgery
Single dose or radiation in 15Gy, 18Gy or 21Gy
Other Names:
  • Radiosurgery
  • External beam radiation therapy

Detailed Description:

This study will assess the safety of partial breast radiosurgery as measured by the incidence of acute toxicity and wound healing complications in three dose cohorts.

Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped for evaluation and consideration of revision. If at most one DLT is observed then escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of irradiation.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast
  • Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
  • Clinical T1N0M0
  • 55 years of age or older
  • Estrogen receptor (ER) positive,
  • No evidence of lymphovascular space invasion on initial biopsy
  • Not pregnant. If not post-menopausal must adhere to birth control measures
  • White blood cell count > 3000, Hemoglobin > 9, platelets >100000
  • Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min

Exclusion Criteria:

  • Neoadjuvant chemotherapy
  • Breast implants
  • Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
  • Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
  • HER-2/neu positive
  • Positive serum pregnancy test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944528

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Janet Horton, MD Duke University Medical Center, Dept of Radiation Oncology
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00944528     History of Changes
Other Study ID Numbers: Pro00015617
Study First Received: July 22, 2009
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Cancer of Breast
Cancer of the Breast
Neoplasms, Breast
Single dose radiation
Radiotherapy
Preoperative

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014