Clinical trial NCT00647582: Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-03-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Feasibility
measure: Acute tolerability
measure: Local tumor control rate
measure: Distant tumor control rate
measure: Long-term side effects
measure: Cosmetic outcome
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: William W. Wong, MD
role: STUDY_CHAIR
References: