NCT02266602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

6.5 years

First QC Date

October 10, 2014

Last Update Submit

April 24, 2019

Conditions

Breast Cancer

Keywords

IORTBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Disease specific and overall survival

    10 years

Study Arms (1)

Treatment

OTHER

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

Radiation: Intraoperative Radiation Therapy

Interventions

Intraoperative Radiation TherapyRADIATION

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

Also known as: IORT
Treatment

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Janie Grumley, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 17, 2014

Study Start

February 1, 2012

Primary Completion

July 30, 2018

Study Completion

July 31, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations

US(1)