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

This study has been completed.

Sponsor:

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01215162

First received: August 7, 2009

Last updated: May 9, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	August 7, 2009
Last Updated Date	May 9, 2013
Start Date ^ICMJE	January 2003
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 4, 2010)	Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer. [ Time Frame: weekly evaluation during 5 weeks of radiation ] [ Designated as safety issue: Yes ] To determine the acute skin reaction, breast edema, pnemonitis, cardiac side effects during radiation using RTOG acute toxicity scale Determine the local tumor control and distant tumor control rates for patients with stage T1/T2N0M0 breast cancer. [ Time Frame: every 6 months follow-up for 5 years, then yearly to end in 04/2013 ] [ Designated as safety issue: No ] 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. [ Time Frame: every 6 months follow-up for 5 years, then yearly to end in 04/2013 ] [ Designated as safety issue: Yes ] To determine the late skin reaction, breast edema, pneumonitis, cardiac side effects during radiation using RTOG late toxicity scale
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01215162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
Official Title ^ICMJE	Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	Radiation: Intra-operative radiation to tumor bed IOERT is given to the tumor bed. Applicator selection should allow treatment of the tumor bed plus 1-2 cm margin. The surgical incision may need to be enlarged slightly to allow the placement of the appropriate applicator. The use of more than 1 treatment field is discouraged. In order to encompass the entire tumor bed in 1 treatment field, it may be necessary to suture the mammary parenchyma loosely so that the lateral margins of the tumor bed are brought into apposition. Electron energy used for the treatment. If the tumor bed can be flattened and encompassed by an applicator, 6 MeV electron is recommended. Use of bolus material may be considered to increase the surface dose. If the mammary parenchyma has been brought into apposition by sutures, a higher electron energy may be necessary to allow adequate dose coverage to a depth of 1.0-2.0 cm into the tumor bed. The dose of IOERT is 1000 cGy, prescribed to the 90% isodose line.
Study Arm (s)	Experimental: Single arm study Patients with stage T1/T2No breast cancer receiving breast conserving treatment Intervention: Radiation: Intra-operative radiation to tumor bed
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	65
Completion Date	January 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Eligibility: Histologically proven primary invasive breast carcinoma. Tumor pathologically determined <= 5cm in diameter. Single, discrete, well-defined primary tumor. Any micro-calcifications must be focal. A specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications. Pathologically negative surgical margins. Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling. ECOG performance status 0-2. Contraindications: Multicentric disease and/or diffuse malignant appearing microcalcifications. Evidence of metastatic breast cancer. Axillary lymph node involvement. Pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy. Prior irradiation to the ara of planned radiation field. Pregnant or lactating women.
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01215162
Other Study ID Numbers ^ICMJE	1681-02, MCS066
Has Data Monitoring Committee	Yes
Responsible Party	William Wong M.D., Mayo Clinic
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mayo Clinic
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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