Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments adjuvant therapy, therapeutic conventional surgery, intraoperative radiation therapy, radiation therapy
Phase phase 2
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date October 2002
End date June 2005
Trial size 80 participants
Trial identifier NCT00647582, 1681-02, CDR0000588774, MCS066, P30CA015083

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Feasibility
time frame:
Acute tolerability
time frame:
Local tumor control rate
time frame:
Distant tumor control rate
time frame:
Long-term side effects
time frame:
Cosmetic outcome
time frame:

Eligibility Criteria

Female participants from 18 years up to 99 years old.

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

Additional Information

Official title Phase II Study of Intra-operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.