Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment

This study has been terminated.
(Study terminated by Principal Investigator; no patients completed study.)
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00409331
First received: December 7, 2006
Last updated: July 31, 2012
Last verified: July 2012
Results First Received: December 11, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Drug: Amifostine
Procedure: Intensity- Modulated Radiation Therapy

  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
Recruitment Period: 06/12/07 through 01/14/08. All participants recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study terminated due to slow accrual and change in sponsor. Three patients registered, two removed prior to study beginning as not eligible.

Reporting Groups
  Description
IMRT + Amifostine Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.

Participant Flow:   Overall Study
    IMRT + Amifostine  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Physician Decision                 1  



  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.
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Reporting Groups
  Description
IMRT + Amifostine Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.

Baseline Measures
    IMRT + Amifostine  
Number of Participants  
[units: participants]
  1  
Age  
[units: years]
Median ( Full Range )
  48  
  ( 48 to 48 )  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   12-month Clinically Relevant Salivary Flow (CRSF)   [ Time Frame: 12 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mark Chambers, DMD / Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-745-2672


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00409331     History of Changes
Other Study ID Numbers: 2006-0234
Study First Received: December 7, 2006
Results First Received: December 11, 2009
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration