Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy (APBI)

July 10, 2013 updated by: Rocky Mountain Cancer Centers

A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers - Aurora
      • Boulder, Colorado, United States, 80303
        • Rocky Mountain Cancer Centers - Boulder
      • Denver, Colorado, United States, 80128
        • Rocky Mountain Cancer Centers - Midtown
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers - Littleton
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers - Sky Ridge
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Centers - Thornton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mammosite
Accelerated Partial Breast Irradiation using Mammosite RTS
Radiation: 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.
Other Names:
  • APBI
  • Mammosite
  • Breast Brachytherapy
  • Accelerated Partial Breast Irradiation
Experimental: IMRT
Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy
Radiation: Intensity Modulated Radiotherapy
Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation
Other Names:
  • EBRT
  • APBI
  • IMRT
  • Accelerated Partial Breast Irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 2-15 years
2-15 years
Disease free survival
Time Frame: 2-15 years
2-15 years
Cause specific survival
Time Frame: 2-15 years
2-15 years
Ipsilateral breast failure
Time Frame: 2-15 years
2-15 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Serious Adverse device-related Events
Time Frame: 2-5 years
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rocky Mountain Cancer Centers

Collaborators

Charles Leonard, MD

Investigators

  • Principal Investigator: Dennis Carter, MD, Rocky Mountain Cancer Centers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

August 18, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimate)

August 19, 2010

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIRB #20040075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Breast Brachytherapy with Mammosite RTS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe