Intraoperative Radiation Therapy in Early Stage Breast Cancer

Breast Cancer Clinical Trial

— IORTBreast  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266602
• Other study ID #: 11143
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: July 31, 2018

Study information

• Verified date: April 2019
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 31, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Intraoperative Radiation Therapy
Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Disease Relapse	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).	10 years
Secondary	Disease specific and overall survival	Disease specific and overall survival will be obtained for all patients in the study.	10 years