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Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00274937
First Posted: January 11, 2006
Last Update Posted: June 8, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
Results First Submitted: October 24, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stage I Lymphoepithelioma of the Nasopharynx
Stage I Squamous Cell Carcinoma of the Nasopharynx
Stage II Lymphoepithelioma of the Nasopharynx
Stage II Squamous Cell Carcinoma of the Nasopharynx
Stage III Lymphoepithelioma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage IV Lymphoepithelioma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Interventions: Drug: amifostine trihydrate
Drug: fluorouracil
Drug: cisplatin
Other: laboratory biomarker analysis
Radiation: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No patients were enrolled to Stratum 1.

Reporting Groups
  Description
Stratum II AJCC Stage IIb - IV

Participant Flow:   Overall Study
    Stratum II
STARTED   111 
COMPLETED   91 
NOT COMPLETED   20 
Physician Decision                10 
Withdrawal by Subject                6 
Progressive Disease                4 



  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
Stratum II AJCC Stage IIb - IV

Baseline Measures
   Stratum II 
Overall Participants Analyzed 
[Units: Participants]
 111 
Age 
[Units: Participants]
Mean (Standard Deviation)
 13.8  (2.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      36  32.4% 
Male      75  67.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      13  11.7% 
Not Hispanic or Latino      95  85.6% 
Unknown or Not Reported      3   2.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   0.9% 
Asian      4   3.6% 
Native Hawaiian or Other Pacific Islander      2   1.8% 
Black or African American      52  46.8% 
White      43  38.7% 
More than one race      0   0.0% 
Unknown or Not Reported      9   8.1% 
Region of Enrollment 
[Units: Participants]
 
Canada   2 
United States   107 
Australia   1 
Saudi Arabia   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Two Year Event-free Survival (EFS)   [ Time Frame: Up to Two Year After Enrollment ]

2.  Secondary:   Predictive Value of the Detection of EBV DNA in the Peripheral Blood   [ Time Frame: Up to 6 years ]

3.  Secondary:   Protective Effects of Amifostine Assessed Primarily by Sialometry   [ Time Frame: At study enrollment ]

4.  Secondary:   Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.   [ Time Frame: At study enrollment ]

5.  Secondary:   Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment   [ Time Frame: At study enrollment ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  

6.  Secondary:   Prognostic Significance of EBV Viral Load   [ Time Frame: At study enrollment ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00274937     History of Changes
Other Study ID Numbers: ARAR0331
NCI-2009-00412 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARAR0331 ( Other Identifier: Children's Oncology Group )
CDR0000454849 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: January 10, 2006
First Posted: January 11, 2006
Results First Submitted: October 24, 2016
Results First Posted: January 19, 2017
Last Update Posted: June 8, 2017