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

NCT ID: NCT00882596

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2013-07-31

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.

Detailed Description

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Accelerated partial breast irradiation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Contura catheter

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 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Center of Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth M Tokita, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Center of Irvine

Richard B Wilder, MD

Role: STUDY_DIRECTOR

Cancer Center of Irvine

Locations

Cancer Center of Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

1098558

Identifier Type: -

Identifier Source: secondary_id

S07-002

Identifier Type: -

Identifier Source: org_study_id