Clinical trial NCT01215162: Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
Official title: Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-10-06
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer.
timeFrame: weekly evaluation during 5 weeks of radiation
measure: Determine the local tumor control and distant tumor control rates for patients with stage T1/T2N0M0 breast cancer.
timeFrame: every 6 months follow-up for 5 years, then yearly to end in 04/2013
measure: Determine long-term side effects and cosmetic outcome of IOERT to tumor bed and EBRT after lumpectomy for patients with stage T1/T2N0Mo breast cancer.
timeFrame: every 6 months follow-up for 5 years, then yearly to end in 04/2013
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
References: