Skip to main content
OpenTrials
Completed

NCT Number: NCT02266602

Intraoperative Radiation Therapy in Early Stage Breast Cancer

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

General Inclusion Criteria

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

Exclusion criteria

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

Treatment and study plan

intraoperative radiation therapy

Radiation

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

Other names: IORT

Primary outcomes

  1. Local Disease Relapse

    Time frame: 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 outcomes

  1. Disease specific and overall survival

    Time frame: 10 years

    Disease specific and overall survival will be obtained for all patients in the study.

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Registry information

Official study title

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

Acronym: IORTBreast

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2014
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.