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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882596
• Other study ID #: S07-002
• Secondary ID: 1098558
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2009
• Last updated: January 23, 2018
• Start date: May 2008
• Est. completion date: July 2013

Study information

• Verified date: January 2018
• Source: Cancer Center of Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Cancer Center of Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Center of Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.		19 months
Secondary	Toxicity rates		79 months

External Links

•   Cancer Center of Irvine