Intraoperative Radiation Therapy in Early Stage Breast Cancer (IORTBreast)

Benaroya Research Institute

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: Intraoperative Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02266602

11143

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: Female

Ages: 45+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

500 participants in 1 patient group

Treatment

Other group

Description:

Patients treated with intraoperative radiation therapy at the time of partial mastectomy.

Treatment:

Radiation: Intraoperative Radiation Therapy