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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Radiation: Intra-operative radiation to tumor bed

Study type: Interventional

Funder types: Other

Identifiers

NCT01215162

MCS066 (Other Identifier)

1681-02 (Other Identifier)

Details and patient eligibility

About

The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually given after EBRT. Data from two centers as well as preliminary data from a randomized trial in Europe suggest that IOERT boost is well tolerated and efficacious. In our study, patients will undergo standard lumpectomy and sentinel lymph node sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy will be delivered in a single fraction to the tumor bed by a mobile electron machine in the operating room. EBRT to the whole breast will be administered once the surgical wound has healed adequately. The primary objective is to determine the feasibility and acute patient tolerance to IOERT and EBRT after lumpectomy. Secondary objectives include assessment of local control and distant control of disease, as well as evaluation of long-term side effects and cosmetic outcome of the treatment.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

65 participants in 1 patient group

Single arm study

Experimental group

Description:

Patients with stage T1/T2No breast cancer receiving breast conserving treatment

Treatment:

Radiation: Intra-operative radiation to tumor bed