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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility

Safety Issue:

No

Principal Investigator

William W. Wong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000588774

NCT ID:

NCT00647582

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms

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