Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2024-08-31

Brief Summary

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Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mammosite

Accelerated Partial Breast Irradiation using Mammosite RTS

Group Type EXPERIMENTAL

Breast Brachytherapy with Mammosite RTS

Intervention Type RADIATION

Treatment will be performed using high dose rate brachytherapy, starting between 2-5 days of implant, 34 Gy at 1 cm in 3.4 Gy fractions BID for 5 treatment days with typical boost dose od 10 Gy given in 2 fractions at least 6 hours apart.

IMRT

Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy

Group Type EXPERIMENTAL

Intensity Modulated Radiotherapy

Intervention Type RADIATION

Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation

Interventions

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Breast Brachytherapy with Mammosite RTS

Treatment will be performed using high dose rate brachytherapy, starting between 2-5 days of implant, 34 Gy at 1 cm in 3.4 Gy fractions BID for 5 treatment days with typical boost dose od 10 Gy given in 2 fractions at least 6 hours apart.

Intervention Type RADIATION

Intensity Modulated Radiotherapy

Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation

Intervention Type RADIATION

Other Intervention Names

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Mammosite Breast Brachytherapy Accelerated Partial Breast Irradiation APBI IMRT APBI EBRT Accelerated Partial Breast Irradiation

Eligibility Criteria

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Inclusion Criteria

* Be a Tis, T1, N0, M0 AJC Classification
* Have negative surgical margins (\> or = 2 mm) after final surgery
* Should have adequate skin spacing between balloon surface and surface the skin (\> 7 mm)\*
* Patients with infiltrating lobular histologies should have breast MRI scanning as part of the initial staging to verify localized T1, or Tis disease
* Multifocal findings (define as 2 or more breast quadrants) on MRI scanning should be further evaluated by ultrasound and, if necessary biopsy, to exclude multiquadrant disease.

Exclusion Criteria

* Be pregnant or breast-feeding
* Have collagen-vascular disease
* Inadequate surgical margins (\< 2 mm)
* Patients with malignant/suspicious calcifications

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No