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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cancer Center of Irvine
ClinicalTrials.gov Identifier:
NCT00882596
First received: April 15, 2009
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Breast Cancer
Device: Accelerated partial breast irradiation
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cancer Center of Irvine:

Primary Outcome Measures:
  • Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose. [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity rates [ Time Frame: 79 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882596

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

Additional Information:
No publications provided

Responsible Party: Cancer Center of Irvine
ClinicalTrials.gov Identifier: NCT00882596     History of Changes
Other Study ID Numbers: S07-002, 1098558
Study First Received: April 15, 2009
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cancer Center of Irvine:
Contura
Cancer
Accelerated
Partial
Breast
Irradiation

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

ClinicalTrials.gov processed this record on November 24, 2014