Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Radiation: brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00214149

2004-0268 (Other Identifier)

RO04102

Details and patient eligibility

About

Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.

Enrollment: 127 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is < 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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127 participants in 1 patient group

1

Experimental group

Description:

breast brachytherapy to a dose of 34 Gy

Treatment:

Radiation: brachytherapy