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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

January 23, 2008
August 9, 2011
January 2005
August 2007   (final data collection date for primary outcome measure)
Toxicity: Up to 3 months post external beam radiation therapy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Acute patient tolerance [ 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 ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00602108 on ClinicalTrials.gov Archive Site
Not Provided
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Radiation Therapy in Treating Women Undergoing Lumpectomy for Stage I or Stage IIA Breast Cancer
Phase II Study of Intra-operative Electron Irradiation and Hypofractionated 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 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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Radiation: hypofractionated radiation therapy
  • Radiation: intraoperative radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00602108
CDR0000583007, P30CA015083, MCS314, 806-04
Yes
William Wailing Wong, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: William W. Wong, MD Mayo Clinic
Mayo Clinic
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP