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:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00647582
First received: March 28, 2008
Last updated: March 24, 2014
Last verified: March 2014
  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:


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
Primary Completion Date: June 2005 (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
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: NCT00647582

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: NCT00647582     History of Changes
Other Study ID Numbers: CDR0000588774, P30CA015083, MCS066, 1681-02
Study First Received: March 28, 2008
Last Updated: March 24, 2014
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 July 31, 2014