RAD001, Cisplatin and Concurrent Radiation for Locally Advanced, Inoperable Head and Neck Cancer

This study has been terminated.
(Pharmaceutical co- re aligned their specialties- no longer will fund H&N ca)
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT01057277
First received: December 9, 2009
Last updated: July 8, 2015
Last verified: July 2015
Results First Received: July 8, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Intervention: Drug: RAD001(Afinitor)

  Participant Flow
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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
RAD001(Afinitor)

Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47

RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT


Participant Flow:   Overall Study
    RAD001(Afinitor)  
STARTED     3  
COMPLETED     3  
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.
No text entered.

Reporting Groups
  Description
RAD001(Afinitor)

Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47

RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT


Baseline Measures
    RAD001(Afinitor)  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     1  
Age  
[units: years]
Mean (Full Range)
  58.6   (49 to 71)  
Gender  
[units: participants]
 
Female     1  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures

1.  Primary:   Response   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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:  
Name/Title: Howard Safran, MD
Organization: Brown University Oncology Research Group (BrUOG)
phone: 4018633000
e-mail: kayla_rosati@brown.edu


No publications provided


Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT01057277     History of Changes
Other Study ID Numbers: BrUOG-H&N-229
Study First Received: December 9, 2009
Results First Received: July 8, 2015
Last Updated: July 8, 2015
Health Authority: United States: Food and Drug Administration