Radiation Therapy in Treating Women Undergoing Lumpectomy for Stage I or Stage IIA Breast Cancer

NCT00602108 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000583007P30CA015083MCS314806-04
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity: Up to 3 months post external beam radiation therapy

  3 months

Interventions

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

hypofractionated radiation therapy RADIATION

intraoperative radiation therapy RADIATION

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• William W. Wong, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: January 28, 2008
• Study Start: January 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: August 10, 2011

Record last verified: 2011-08