Radiation Therapy in Treating Women Undergoing Lumpectomy for Stage I or Stage IIA Breast Cancer - Full Text View

Sponsors and Collaborators:	Mayo Clinic Scottsdale National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00602108

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy after lumpectomy followed by external-beam radiation therapy may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well radiation therapy works in treating women undergoing lumpectomy for stage I or stage IIA breast cancer.

Condition	Intervention	Phase
Breast Cancer	Procedure: adjuvant therapy Procedure: conventional surgery Procedure: hypofractionated radiation therapy Procedure: intraoperative radiation therapy	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of Intra-Operative Electron Irradiation and Hypofractionated External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Acute patient tolerance [ Designated as safety issue: Yes ]
Local tumor control rate [ Designated as safety issue: No ]
Distant tumor control rate [ Designated as safety issue: No ]
Long-term side effects [ Designated as safety issue: Yes ]
Cosmetic outcome [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	January 2005
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To determine the feasibility and acute patient tolerance of intraoperative electron irradiation (IOERT) and hypofractionated external-beam irradiation (HYPORT) after lumpectomy for patients with stage I-IIA breast cancer treated with breast conservation therapy.
To determine the local tumor control and distant tumor control rates for patients with stage I-IIA breast cancer treated with breast conservation therapy using IOERT and HYPORT after lumpectomy.
To determine the long-term side effects and cosmetic outcome of IOERT to tumor bed and HYPORT after lumpectomy for patients with stage I-IIA breast cancer.

OUTLINE: Patients undergo lumpectomy per standard procedures. Patients undergo intraoperative electron irradiation (IOERT) to the tumor bed right after completion of lumpectomy with axillary lymph node dissection or sentinel lymph node biopsy.

Beginning 2-6 weeks after lumpectomy with axillary lymph node dissection/sentinel lymph node sampling and IOERT, patients receive hypofractionated external-beam irradiation once daily for 16 days.

After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter for 8 years.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary invasive breast carcinoma
- Stage I-IIA disease (T1, N0, M0 or T2, N0, M0)
- Pathologically determined single, discrete, and well-defined primary tumor ≤ 5 cm in diameter
  - Pathologically negative surgical margins
No multicentric disease and/or diffuse malignant appearing microcalcifications
- Micro-calcifications must be focal
  - Specimen radiograph is required after lumpectomy for tumors associated with malignant appearing calcifications to assure removal of all malignant appearing calcifications
  - Specimen radiograph is optional if the tumor appears as a discrete mass on mammogram
No axillary lymph node involvement
No evidence of metastatic breast cancer
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Menopausal status not specified
No pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy
Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

No prior irradiation to the area of planned radiation field
No prior placement of breast prosthesis in the treated breast
Concurrent hormonal therapy with external-beam irradiation allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602108

Sponsors and Collaborators

Mayo Clinic Scottsdale

National Cancer Institute (NCI)

Investigators

Study Chair:	William W. Wong, MD	Mayo Clinic Scottsdale
Investigator:	Barbara A. Pockaj, MD	Mayo Clinic Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000583007, MAYO-MCS314
Study First Received:	January 23, 2008
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00602108
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009