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Trial record 1 of 1 for:    NCT01754519
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Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery

This study has been terminated.
(IDE not submitted)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cianna Medical, Inc.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01754519
First received: November 23, 2012
Last updated: June 7, 2017
Last verified: June 2017
Results First Received: May 15, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Ductal Breast Carcinoma In Situ
Estrogen Receptor Negative
Estrogen Receptor Positive
HER2/Neu Negative
Invasive Cribriform Breast Carcinoma
Invasive Ductal Carcinoma, Not Otherwise Specified
Lobular Breast Carcinoma In Situ
Mucinous Breast Carcinoma
Papillary Breast Carcinoma
Progesterone Receptor Positive
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIC Breast Cancer
Tubular Breast Carcinoma
Interventions: Procedure: Therapeutic Conventional Surgery
Radiation: Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Radiation Therapy)

Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.

Therapeutic Conventional Surgery: Undergo wide local excision breast surgery

Radiation Therapy: Undergo SFRT

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies


Participant Flow:   Overall Study
    Treatment (Radiation Therapy)
STARTED   1 
COMPLETED   1 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated and eligible patients

Reporting Groups
  Description
Treatment (Radiation Therapy)

Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.

Therapeutic Conventional Surgery: Undergo wide local excision breast surgery

Radiation Therapy: Undergo SFRT

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies


Baseline Measures
   Treatment (Radiation Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 65 [1] 
[1] 1 participant
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1 100.0% 
Male      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Up to 2 years ]

2.  Primary:   Quality-of-life Assessments   [ Time Frame: Up to 2 years ]

3.  Primary:   Cosmetic Differences in the Treated Breast   [ Time Frame: Up to 2 years ]

4.  Secondary:   Locoregional Control Rate   [ Time Frame: At 5 years ]

5.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]

6.  Secondary:   Disease Specific Survival   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01754519     History of Changes
Other Study ID Numbers: I 108907
NCI-2009-01568 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 108907 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
Study First Received: November 23, 2012
Results First Received: May 15, 2017
Last Updated: June 7, 2017