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Completed

NCT Number: NCT00882596

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

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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cancer Center of Irvine

Irvine, California, 92618, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accelerated partial breast irradiation

Device

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

Primary outcomes

  1. Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.

    Time frame: 19 months

Secondary outcomes

  1. Toxicity rates

    Time frame: 79 months

Sponsors and collaborators

Lead sponsor

Cancer Center of Irvine

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2009
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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