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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00647582
First received: March 28, 2008
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Procedure: adjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: intraoperative radiation therapy
Radiation: radiation therapy
 Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]
  • Acute tolerability [ 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 ]

Estimated Enrollment: 80
Study Start Date: October 2002
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647582

Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: William W. Wong, MD Mayo Clinic
  More Information

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

No publications provided

Responsible Party: William Wailing Wong, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00647582     History of Changes
Other Study ID Numbers: CDR0000588774, P30CA015083, MCS066, 1681-02
Study First Received: March 28, 2008
Last Updated: May 22, 2012
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013