Use of the Contura™ Catheter to Deliver Accelerated Partial Breast Irradiation to "Low-risk" Breast Cancer Patients

January 23, 2018 updated by: Cancer Center of Irvine

A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity

The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

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
    • California
      • Irvine, California, United States, 92618
        • Cancer Center of Irvine

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Able and willing to sign informed consent
  • Age 50 or older at diagnosis
  • Life expectancy greater than 10 years (excluding diagnosis of breast cancer)
  • Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria)
  • On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma
  • For patients with invasive breast cancer, an axillary staging procedure must be performed [either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative]
  • The T stage must be Tis, T1, or T2. If T2, the tumor must be less than or equal to 3.0 cm in maximum diameter
  • Estrogen receptor positive tumor

Exclusion Criteria:

  • Age < 50 at diagnosis (regardless of histology)
  • Pregnant or breast-feeding
  • Active collagen vascular disease
  • Paget's disease of the breast
  • Prior history of DCIS or invasive breast cancer
  • Prior breast or thoracic radiation therapy for any condition
  • Multicentric carcinoma (DCIS or invasive)
  • Synchronous bilateral invasive or non-invasive breast cancer
  • Surgical margins that cannot be microscopically assessed or that are positive
  • Positive axillary node(s)
  • T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage of T3 or T4
  • Estrogen receptor negative tumor

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Contura accelerated partial breast irradiation. Following a lumpectomy, a Contura balloon catheter is placed in the lumpectomy cavity. Later that morning, accelerated partial breast irradiation begins.
Device: Accelerated partial breast irradiation
A total radiation dose of 34 Gy is delivered in 10 fractions bid over 5-7 days with 6 hours between the radiation treatments each day. Each radiation treatment takes 15-30 minutes. There is no radioactivity left behind in the patient.
Other Names:
  • Contura catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.
Time Frame: 19 months
19 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity rates
Time Frame: 79 months
79 months

Collaborators and Investigators

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

Sponsor

Cancer Center of Irvine

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

May 1, 2008

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (ESTIMATE)

April 16, 2009

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S07-002
  • 1098558

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 Accelerated partial breast irradiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe