NCT02040493

Brief Summary

This is a physician sponsored multi-center, non-randomized, prospectively enrolling data collection study of patients with early stage breast cancer treated with electronic brachytherapy at the time of surgical resection of the cancer in the operating room. The radiation therapy treatments will be administered with electronic brachytherapy using the FDA cleared Xoft Axxent System.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

7 active sites

Status
terminated

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

September 1, 2008

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2016

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

8.1 years

First QC Date

January 16, 2014

Last Update Submit

July 24, 2017

Conditions

Breast Cancer

Keywords

breast cancerIORTbrachytherapy

Outcome Measures

Primary Outcomes (2)

  • Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer.

    Local recurrence will be assessed at one (1) month, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.

    5 Years

  • Occurence of serious adverse events during and following IORT treatment.

    Serious adverse events are defined as a serious injury or illness that: 1. is life threatening, even if temporary in nature; 2. results in permanent impairment of a body function or permanent damage to a body structure; or 3. necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

    5 Years

Secondary Outcomes (1)

  • Cosmesis

    5 Years

Study Arms (1)

Intra-operative radiation therapy (IORT)

EXPERIMENTAL

IORT

Radiation: Intra-operative radiation therapy (IORT)

Interventions

Intra-operative radiation therapy (IORT)RADIATION

All subjects will receive IORT at the time of lumpectomy.

Intra-operative radiation therapy (IORT)

Eligibility Criteria

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

You may qualify if:

  • Age \> 45 years
  • Tumor with Tis, T1, T2 (≤ 3cm), N0, M0 - (AJC Classification)
  • Invasive ductal carcinoma and / or DCIS
  • Negative sentinel node assessment
  • Balloon surface to skin distance of at least 1-cm and adequate conformance via Intra-operative ultrasound
  • \*\*If positive margins patient my undergo re-excision and/or additional radiation at the treating physician's discretion but the patient will be excluded from the protocol data analysis.

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
  • Intra-operative positive sentinel lymph node biopsy
  • Inadequate conformance (greater than 10% of PTV encompassed by fluid or air on physician assessment of intraOp ultrasound image)
  • Skin spacing less than 1-cm via intraOp ultrasound.
  • A cavity size that is not appropriate for a 40 -70 cc balloon.
  • Patient becomes unstable and physician determines patient is not a good candidate at time of lumpectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cancer Treatment Services Arizona

Casa Grande, Arizona, 85122, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Diablo Valley Oncology Hematology

Pleasant Hill, California, 94523, United States

Location

Little Company of Mary Hospital

Evergreen Park, Illinois, 60805, United States

Location

Rockford Memorial Hospital

Rockford, Illinois, 61103, United States

Location

Exeter Hospital

Exeter, New Hampshire, 03833, United States

Location

Parkridge

Chattanooga, Tennessee, 37404, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Adam Dickler, MD

    Little Company of Mary Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

September 1, 2008

Primary Completion

October 4, 2016

Study Completion

October 4, 2016

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

US(7)