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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

NCT00185744 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2026-03-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Frederick M. Dirbas · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2029-03-31
Completion
2029-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00185744 on ClinicalTrials.gov