Intraoperative Radiation Therapy in Early Stage Breast Cancer

Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02266602

Acronym

IORTBreast

Enrollment

500

Registered

2014-10-17

Start date

2012-02-29

Completion date

2018-07-31

Last updated

2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

IORT, Breast Cancer

Brief summary

Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.

Detailed description

The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of: * Local recurrence in early stage breast cancer patients treated with IORT. * Toxicity associated with IORT. * Long-term disease-specific and overall survival * Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT. * Quality of life in patients treated with IORT. * Health care costs associated with IORT.

Interventions

RADIATIONIntraoperative Radiation Therapy

Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

General Inclusion Criteria 1. Age ≥ 45 years. 2. Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification). 3. Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.

Exclusion criteria

1. Scleroderma, systemic sclerosis and active lupus. 2. Participation in an investigational drug or device study. 3. Previous ipsilateral radiation to the thorax or breast. 4. Multifocal breast cancer. 5. Pregnant patients. 6. Patient not competent to provide informed consent. 7. Neoadjuvant systemic therapy. 8. Lymphovascular invasion on biopsy pathology

Design outcomes

Primary

Measure	Time frame	Description
Local Disease Relapse	10 years	Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).

Secondary

Measure	Time frame	Description
Disease specific and overall survival	10 years	Disease specific and overall survival will be obtained for all patients in the study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026