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

March 20, 2018 updated by: Mayo Clinic

Phase II Study of Intra-operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: William W. Wong, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

December 21, 2013

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000588774
  • P30CA015083 (U.S. NIH Grant/Contract)
  • MCS066 (Mayo Clinic Cancer Center)
  • 1681-02 (Mayo Clinic IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe