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Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer

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: NCT01463007
Recruitment Status : Active, not recruiting
First Posted : November 1, 2011
Results First Posted : August 21, 2015
Last Update Posted : December 25, 2018
Sponsor:
Collaborators:
The Miriam Hospital
Rhode Island Hospital
Information provided by (Responsible Party):
Jaroslaw Hepel, Brown University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Radiation: Accelerated partial breast irradiation
Other: Extended Follow up
Enrollment 40
Recruitment Details  
Pre-assignment Details 40 patients must COMPLETE treatment. 41 were registered because 1 was removed secondary to Physician decision to not continue treatment.
Arm/Group Title Radiation
Hide Arm/Group Description

AccuBoost APBI- 34.0 Gy in 10fx

Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions

Period Title: Overall Study
Started 41
Completed 40
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Radiation
Hide Arm/Group Description

AccuBoost APBI- 34.0 Gy in 10fx

Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions

Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  39.0%
>=65 years
25
  61.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants
61.46
(50 to 92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
41
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants
41
1.Primary Outcome
Title Early and Intermediate Toxicity
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 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation Extended to 5 Years of Follow Up-Rhode Island Hospital Only
Hide Arm/Group Description:

AccuBoost APBI- 34.0 Gy in 10fx

Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions

Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.
Overall Number of Participants Analyzed 41 28
Measure Type: Number
Unit of Measure: participants
40 28
2.Secondary Outcome
Title Cosmetic Outcome
Hide Description Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation
Hide Arm/Group Description:

AccuBoost APBI- 34.0 Gy in 10fx

Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions

Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: participants
35
Time Frame Data was collected from signing of ICF until 2 years post treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiation
Hide Arm/Group Description

AccuBoost APBI- 34.0 Gy in 10fx

Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions

All-Cause Mortality
Radiation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Radiation
Affected / at Risk (%) # Events
Total   1/41 (2.44%)    
Investigations   
Infection   1/41 (2.44%)  1
Creatinine   1/41 (2.44%)  1
Hypokalemia   1/41 (2.44%)  1
Bicarbonate   1/41 (2.44%)  1
SGOT   1/41 (2.44%)  1
Alkaline Phosphatase value   1/41 (2.44%)  1
Hyperbilirubineamia   1/41 (2.44%)  1
Hypoalbuminemia   1/41 (2.44%)  1
Leukocytes   1/41 (2.44%)  1
Hemoglobin   1/41 (2.44%)  1
Neutrophils   1/41 (2.44%)  1
INR   1/41 (2.44%)  1
PTT   1/41 (2.44%)  1
Fibrinogen   1/41 (2.44%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiation
Affected / at Risk (%) # Events
Total   40/41 (97.56%)    
Investigations   
Discomfort   35/41 (85.37%)  35
acute skin rxn   32/41 (78.05%)  32
skin induration/fibrosis   11/41 (26.83%)  11
hyperpigmentation   22/41 (53.66%)  22
fatigue   18/41 (43.90%)  18
breast volume   11/41 (26.83%)  11
seroma   2/41 (4.88%)  2
fat necrosis   2/41 (4.88%)  2
Itching   0/41 (0.00%)  0
Fibrosis Cosmesis   1/41 (2.44%)  1
Talangiectasis   8/41 (19.51%)  8
breast pain   7/41 (17.07%)  7
Nausea   1/41 (2.44%)  1
Diarrhea   1/41 (2.44%)  1
erythema   1/41 (2.44%)  1
Indicates events were collected by systematic assessment
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: Dr. Jaroslaw Hepel
Organization: BrUOG-Brown University Oncology Research Group
Phone: 4018633000
EMail: kristen_mitchell@brown.edu
Layout table for additonal information
Responsible Party: Jaroslaw Hepel, Brown University
ClinicalTrials.gov Identifier: NCT01463007     History of Changes
Other Study ID Numbers: BrUOG 251
First Submitted: July 21, 2011
First Posted: November 1, 2011
Results First Submitted: June 24, 2015
Results First Posted: August 21, 2015
Last Update Posted: December 25, 2018