Single Dose Partial Breast Radiotherapy (RSU)
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.
|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|
- Maximum Tolerated Dose [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]as measured by the incidence of acute toxicity and wound healing complications
- Local control [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
- Cosmetic outcome [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Single dose radiosurgery
A single dose of radiation given in radiosurgery technique about 3 weeks before lumpectomy.
Single dose or radiation in 15Gy, 18Gy or 21Gy
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.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Janet Horton, MD||Duke University Medical Center, Dept of Radiation Oncology|