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Single Dose Partial Breast Radiotherapy (RSU)

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ClinicalTrials.gov Identifier: NCT00944528
Recruitment Status : Active, not recruiting
First Posted : July 23, 2009
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE July 22, 2009
First Posted Date  ICMJE July 23, 2009
Last Update Posted Date March 1, 2019
Study Start Date  ICMJE January 2010
Actual Primary Completion Date April 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
Maximum Tolerated Dose [ Time Frame: 30 days ]
As measured by the incidence of acute toxicity and wound healing complications
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
Maximum Tolerated Dose as measured by the incidence of acute toxicity and wound healing complications [ Time Frame: 24 months ]
Change History Complete list of historical versions of study NCT00944528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
  • Local control [ Time Frame: 3 yrs ]
  • Cosmetic outcome [ Time Frame: 3 yrs ]
  • Magnetic Resonance Images(MRI) [ Time Frame: Pre and post SRS radiosurgery ]
    Pre and post-radiotherapy for exploratory analysis of radiation response.
  • Acquire tissue [ Time Frame: Pre and post SRS radiosurgery ]
    Pre and post-radiotherapy for exploratory analysis of radiation response
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
  • Local control [ Time Frame: 2 yrs ]
  • Cosmetic outcome [ Time Frame: 2 yrs ]
  • Exploratory analysis of radiation response using magnetic resonance imaging (MR) and proteomic analysis pre and post-radiotherapy [ Time Frame: 2 yrs ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose Partial Breast Radiotherapy
Official Title  ICMJE Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Radiation: Radiosurgery
Single dose or radiation in 15Gy, 18Gy or 21Gy
Other Name: External beam radiation therapy
Study Arms
  • Experimental: Single dose radiosurgery: Dose Level 1
    A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
    Intervention: Radiation: Radiosurgery
  • Experimental: Single dose radiosurgery: Dose Level 2
    A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
    Intervention: Radiation: Radiosurgery
  • Experimental: Single dose radiosurgery: Dose Level 3
    A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
    Intervention: Radiation: Radiosurgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2009)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 2023
Actual Primary Completion Date April 4, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00944528
Other Study ID Numbers  ICMJE Pro00015617
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rachel Blitzblau, MD PhD Duke University Medical Center, Dept of Radiation Oncology
PRS Account Duke University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP