Single Dose Partial Breast Radiotherapy

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00944528
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	Phase 1
Start date	July 28, 2010
Completion date	March 25, 2023

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Single Dose Partial Breast Radiotherapy — RSU

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms