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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647582
• Other study ID #: CDR0000588774
• Secondary ID: P30CA015083MCS06
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2008
• Last updated: March 20, 2018
• Start date: October 2002
• Est. completion date: December 21, 2013

Study information

• Verified date: April 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 21, 2013
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• adjuvant therapy

• therapeutic conventional surgery

Radiation:
• intraoperative radiation therapy

• radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility
Primary	Acute tolerability
Primary	Local tumor control rate
Primary	Distant tumor control rate
Primary	Long-term side effects
Primary	Cosmetic outcome