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

NCT00882596 | Completed Phase 4 DMC

• 2 other identifiers: S07-0021098558
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Contura; Cancer; Accelerated; Partial; Breast; Irradiation

Outcome Measures

Primary Outcomes (1)

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

  19 months

Secondary Outcomes (1)

• Toxicity rates

  79 months

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

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.

Also known as: Contura catheter

1

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Center of Irvine: lead

Study Sites (1)

Cancer Center of Irvine

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kenneth M Tokita, MD

  Cancer Center of Irvine

  PRINCIPAL INVESTIGATOR

• Richard B Wilder, MD

  Cancer Center of Irvine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: May 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

US (1)