Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer

NCT ID: NCT00647582

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2013-12-21

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy during and after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of giving radiation therapy during and after lumpectomy and to see how well it works in treating women with stage I or stage II breast cancer.

Detailed Description

OBJECTIVES:

• To determine the feasibility and acute tolerability of intraoperative electron radiotherapy (IOERT) and external-beam radiotherapy (EBRT) after lumpectomy in women with stage I or II breast cancer treated with breast conservation therapy.
• To determine the local tumor control and distant tumor control rates in these patients.
• To determine the long-term side effects and cosmetic outcome of IOERT to the tumor bed and EBRT after lumpectomy in these patients.

OUTLINE: Patients undergo standard lumpectomy. Patients with negative lymph nodes undergo intraoperative electron radiotherapy to the tumor bed. Beginning 2-8 weeks after surgery, patients undergo whole breast external beam radiotherapy once daily for 24-27 fractions.

After completion of study treatment, patients are followed periodically for up to 8 years.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

adjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

intraoperative radiation therapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary invasive breast carcinoma, meeting the following criteria:

• Stage I or II disease (T1-T2, N0, M0)
• Tumor pathologically determined to be ≤ 5 cm in diameter
• Single, discrete, well-defined primary tumor
• No multicentric disease and/or diffuse malignant appearing microcalcifications

• Any microcalcifications must be focal

• Specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications
• No axillary lymph node involvement

• Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling
• Must have pathologically negative surgical margins
• No evidence of metastatic breast cancer
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Menopausal status not specified
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy

PRIOR CONCURRENT THERAPY:

• No prior irradiation to the area of planned radiation field
• Concurrent hormone therapy allowed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic Cancer Center

Principal Investigators

William W. Wong, MD

Role: STUDY_CHAIR

Mayo Clinic

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

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MCS066

Identifier Type: OTHER

Identifier Source: secondary_id

1681-02

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000588774

Identifier Type: -

Identifier Source: org_study_id