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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00602108
First received: January 23, 2008
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: hypofractionated radiation therapy
Radiation: intraoperative 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 Hypofractionated External Beam Irradiation After Lumpectomy in Patients With Stage T1N0M0 or T2N0M0 Breast Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Toxicity: Up to 3 months post external beam radiation therapy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: January 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine the feasibility and acute patient tolerance of intraoperative electron irradiation (IOERT) and hypofractionated external-beam irradiation (HYPORT) after lumpectomy for patients with stage I-IIA breast cancer treated with breast conservation therapy.
  • To determine the local tumor control and distant tumor control rates for patients with stage I-IIA breast cancer treated with breast conservation therapy using IOERT and HYPORT after lumpectomy.
  • To determine the long-term side effects and cosmetic outcome of IOERT to tumor bed and HYPORT after lumpectomy for patients with stage I-IIA breast cancer.

OUTLINE: Patients undergo lumpectomy per standard procedures. Patients undergo intraoperative electron irradiation (IOERT) to the tumor bed right after completion of lumpectomy with axillary lymph node dissection or sentinel lymph node biopsy.

Beginning 2-6 weeks after lumpectomy with axillary lymph node dissection/sentinel lymph node sampling and IOERT, patients receive hypofractionated external-beam irradiation once daily for 16 days.

After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter for 8 years.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602108

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: William W. Wong, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: William Wailing Wong, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00602108     History of Changes
Other Study ID Numbers: CDR0000583007, P30CA015083, MCS314, 806-04
Study First Received: January 23, 2008
Last Updated: August 9, 2011
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 September 29, 2014