Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer

NCT ID: NCT01008514

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

Brief Summary

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.

Detailed Description

OBJECTIVES:

Primary

• To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.

Secondary

• To assess the toxicities associated with MammoSite® RTS in these patients.
• To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
• To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
• To correlate the local recurrence rate with time between surgery and implant.

OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device into the cavity where the tumor was removed either at the time of surgery or percutaneously under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.

After completion of study therapy, patients are followed up periodically for 5 years.

Conditions

Breast Cancer

Study Design

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

Interventions

adjuvant therapy

Intervention Type: PROCEDURE

accelerated partial breast irradiation

Intervention Type: RADIATION

intracavitary balloon brachytherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive breast adenocarcinoma

• Stage 0, I, or II (T2, N0; tumor size ≤ 3 cm) disease
• Pathologic staging of the axilla preferred

• Clinical staging of the axilla allowed for patients ≥ 70 years of age with hormone receptor-positive tumors
• Unicentric tumor

• Microscopic multifocality allowed as long as the total tumor size is ≤ 3 cm
• Must have undergone lumpectomy as definitive surgery

• Negative surgical margins, defined as no tumor at the inked margin of resection after final surgery

• Re-excision to obtain negative margins allowed
• Must have adequate skin spacing between balloon surface and surface of the skin and lung (≥ 7 mm)
• No multicentric carcinoma (invasive or DCIS) in more than one quadrant
• No clinically or pathologically positive regional lymph nodes
• No extensive intraductal component, defined as DCIS extending beyond the primary invasive component into normal breast parenchyma and composing > 25% of the primary tumor
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No collagen-vascular disease, including any of the following:

• Dermatomyositis
• Systemic lupus erythematosus
• Scleroderma-mixed connective tissue disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

OSU-08177

Identifier Type: -

Identifier Source: org_study_id