Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments breast brachytherapy with mammosite rts, intensity modulated radiotherapy
Phase phase 2
Sponsor Rocky Mountain Cancer Centers
Collaborator Charles Leonard, MD
Start date February 2004
End date August 2014
Trial size 291 participants
Trial identifier NCT01185145, WIRB #20040075

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Accelerated Partial Breast Irradiation using Mammosite RTS
breast brachytherapy with mammosite rts Mammosite
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.
(Experimental)
Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy
intensity modulated radiotherapy IMRT
Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation

Primary Outcomes

Measure
Overall Survival
time frame: 2-15 years
Disease free survival
time frame: 2-15 years
Cause specific survival
time frame: 2-15 years
Ipsilateral breast failure
time frame: 2-15 years

Secondary Outcomes

Measure
Serious Adverse device-related Events
time frame: 2-5 years

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy
Principal investigator Dennis Carter, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Rocky Mountain Cancer Centers.