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Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer

Inclusion Criteria


Eligibility:

1. Histologically proven primary invasive breast carcinoma.

2. Tumor pathologically determined <= 5cm in diameter.

3. Single, discrete, well-defined primary tumor.

4. Any micro-calcifications must be focal. A specimen radiograph is required after
lumpectomy to assure removal of all malignant appearing calcifications.

5. Pathologically negative surgical margins.

6. Axillary lymph node status can be determined by level I and II lymph node dissection
or sentinel lymph node sampling.

7. ECOG performance status 0-2.

Contraindications:

1. Multicentric disease and/or diffuse malignant appearing microcalcifications.

2. Evidence of metastatic breast cancer.

3. Axillary lymph node involvement.

4. Pre-existing collagen vascular disease except rheumatoid arthritis that does not
require immunosuppressive therapy.

5. Prior irradiation to the ara of planned radiation field.

6. Pregnant or lactating women.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer.

Outcome Description:

To determine the acute skin reaction, breast edema, pnemonitis, cardiac side effects during radiation using RTOG acute toxicity scale

Outcome Time Frame:

weekly evaluation during 5 weeks of radiation

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

1681-02

NCT ID:

NCT01215162

Start Date:

January 2003

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic Scottsdale, Arizona