NCT00185744

Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.

Conditions

• Breast Cancer
• Carcinoma, Ductal

Interventions

Type	Name	Description
RADIATION	Intra-Operative Radiotherapy (IORT)	single dose in the operating room after lumpectomy
PROCEDURE	Lumpectomy
RADIATION	Whole Breast Radiotherapy	six and a half week treatment
RADIATION	Intracavitary Brachytherapy	5 day treatment
RADIATION	Accelerated External Beam 3-D Conformal Radiotherapy	5 day treatment
RADIATION	Stereotactic APBI	4 day treatment

Timeline

• Start date: 2002-09-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2005-09-16
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study