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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00882596
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):
Cancer Center of Irvine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Accelerated partial breast irradiation Phase 4

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  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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 Name: Contura catheter

Primary Outcome Measures :
  1. Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose. [ Time Frame: 19 months ]

Secondary Outcome Measures :
  1. Toxicity rates [ Time Frame: 79 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00882596

United States, California
Cancer Center of Irvine
Irvine, California, United States, 92618
Sponsors and Collaborators
Cancer Center of Irvine
Principal Investigator: Kenneth M Tokita, MD Cancer Center of Irvine
Study Director: Richard B Wilder, MD Cancer Center of Irvine

Additional Information:
Responsible Party: Cancer Center of Irvine Identifier: NCT00882596     History of Changes
Other Study ID Numbers: S07-002
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Cancer Center of Irvine:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases