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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Intra-operative radiation to tumor bed

• Registration Number: NCT01215162
• Lead Sponsor: Mayo Clinic

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 available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2005-01
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-06
• Study Completion: 2013-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	Intra-operative radiation to tumor bed	Patients with stage T1/T2No breast cancer receiving breast conserving treatment

Primary Outcome Measures

Name	Time	Method
Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer.	weekly evaluation during 5 weeks of radiation	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.	every 6 months follow-up for 5 years, then yearly to end in 04/2013
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.	every 6 months follow-up for 5 years, then yearly to end in 04/2013	To determine the late skin reaction, breast edema, pneumonitis, cardiac side effects during radiation using RTOG late toxicity scale

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States