Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01961531
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Results First Posted : August 25, 2020
Last Update Posted : November 3, 2021
Sponsor:
Collaborators:
Watson cancer center
Cancer Treatment Centers of America
University of California, San Diego
Information provided by (Responsible Party):
Jaroslaw Hepel, Brown University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Device: Accuboost APBI
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Accuboost APBI
Hide Arm/Group Description

28Gy delivered in 5 daily fractions

Accuboost APBI: 28Gy delivered in 5 daily fractions

Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title Accuboost APBI
Hide Arm/Group Description

28Gy delivered in 5 daily fractions

Accuboost APBI: 28Gy delivered in 5 daily fractions

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  35.0%
>=65 years
26
  65.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
67.45
(50 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
40
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
40
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   2.5%
White
39
  97.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Number of Patients With Any Toxicity Related to the Radiation Treatment
Hide Description Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Time Frame during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Accuboost APBI
Hide Arm/Group Description:

28Gy delivered in 5 daily fractions

Accuboost APBI: 28Gy delivered in 5 daily fractions

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
40
 100.0%
2.Secondary Outcome
Title Number of Participants With Ipsilateral Breast Local Recurrence
Hide Description [Not Specified]
Time Frame annually for 2 years post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Accuboost APBI
Hide Arm/Group Description:

28Gy delivered in 5 daily fractions

Accuboost APBI: 28Gy delivered in 5 daily fractions

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.0%
Time Frame Data was collected from signing of ICF until 5 years post treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Accuboost APBI
Hide Arm/Group Description

28Gy delivered in 5 daily fractions

Accuboost APBI: 28Gy delivered in 5 daily fractions

All-Cause Mortality
Accuboost APBI
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Accuboost APBI
Affected / at Risk (%)
Total   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Accuboost APBI
Affected / at Risk (%)
Total   36/40 (90.00%) 
General disorders   
Discomfort  1  27/40 (67.50%) 
Fatigue  1  19/40 (47.50%) 
Edema  1  1/40 (2.50%) 
Shoulder Pain  1  1/40 (2.50%) 
Infections and infestations   
Contralateral Breast Infection  1  1/40 (2.50%) 
Folliculitis  1  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders   
Seroma  1  2/40 (5.00%) 
Fibrosis-cosmesis  1  3/40 (7.50%) 
Reproductive system and breast disorders   
Breast Soreness  1  1/40 (2.50%) 
Breast Volume/Hypoplasia  1  11/40 (27.50%) 
Breast Tenderness  1  1/40 (2.50%) 
Breast Pain  1  5/40 (12.50%) 
Skin and subcutaneous tissue disorders   
Acute Skin Reaction  1  32/40 (80.00%) 
Skin Induration/Fibrosis  1  8/40 (20.00%) 
Hyperpigmentation  1  7/40 (17.50%) 
Pruritus  1  2/40 (5.00%) 
Telangiectasia  1  13/40 (32.50%) 
Skin Atrophy  1  3/40 (7.50%) 
Hypopigmentation  1  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jaroslaw Hepel, MD
Organization: BrUOG- Brown University Oncology Research Group
Phone: 401-863-3000
EMail: BrUOG@brown.edu
Layout table for additonal information
Responsible Party: Jaroslaw Hepel, Brown University
ClinicalTrials.gov Identifier: NCT01961531    
Other Study ID Numbers: 291
First Submitted: October 10, 2013
First Posted: October 11, 2013
Results First Submitted: January 27, 2020
Results First Posted: August 25, 2020
Last Update Posted: November 3, 2021