Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 12, 2008

Last Updated Date

March 6, 2009

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00699101 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy

Official Title ^†

A Multi-Site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use

Brief Summary

This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.

Detailed Description

Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study

Condition ^†

Breast Cancer

Intervention ^†

Device: Contura Multi-Lumen Balloon

Study Arms / Comparison Groups

Experimental: Contura Multi-Lumen Balloon

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

342

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility 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 or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:
1. sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
2. axillary dissection (minimum of six axillary nodes removed); and
3. the axillary node(s) must be pathologically negative.
The T stage must be Tis, T1, or T2. If T2, the tumor must be ≤ 3.0 cm in maximum diameter.
Estrogen receptor positive tumor

Exclusion Criteria:

Age < 50 at diagnosis (regardless of histology)
Pregnant or breast-feeding (if appropriate, patient must use birth control during the study)
Active collagen-vascular disease
Paget's disease of the breast
History of DCIS or invasive breast cancer
Prior breast or thoracic RT 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 or close
Positive axillary node(s)
T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage > 3
Estrogen receptor negative tumor

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Natasha Behrmann

949-362-4800 ext 145

nbehrmann@senorx.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00699101

Responsible Party

Douglas W. Arthur, MD, Virginia Commonwealth University

Secondary IDs ^††

Study Sponsor ^†

Virginia Commonwealth University

Collaborators ^††

Investigators ^†

Study Chair:

Douglas W. Arthur, MD

Virginia Commonwealth University

Information Provided By

Virginia Commonwealth University

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.