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Trial record 17 of 64 for:    dry mouth | NIH

Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT00057785
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : October 13, 2014
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Head and Neck Cancer
Oral Complications of Radiation Therapy
Radiation Toxicity
Interventions: Drug: cisplatin
Drug: fluorouracil
Radiation: Intensity modulated radiation therapy

  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
IMRT +/- Chemotherapy Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

Participant Flow:   Overall Study
    IMRT +/- Chemotherapy
STARTED   68 
COMPLETED   68 [1] 
NOT COMPLETED   0 
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  Baseline Characteristics

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 eligible patients

Reporting Groups
  Description
IMRT +/- Chemotherapy Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

Baseline Measures
   IMRT +/- Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
 68 
Age 
[Units: Years]
Median (Full Range)
 48.5 
 (18 to 73) 
Gender 
[Units: Participants]
Count of Participants
 
Female      17  25.0% 
Male      51  75.0% 


  Outcome Measures

1.  Primary:   Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered   [ Time Frame: From start of treatment to end of treatment ]

2.  Secondary:   Rate of Xerostomia at 1 Year (Grade ≥ 2)   [ Time Frame: From start of treatment to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Rate of Locoregional Control at 2 Years   [ Time Frame: From registration to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Whole Mouth Saliva Output Relative to Pretreatment Measurements   [ Time Frame: From start of treatment to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Other Acute and Late Toxicities   [ Time Frame: From start of treatment to last follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Chemotherapy Compliance   [ Time Frame: From start of treatment to end of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information

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: Wendy Seiferheld
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00057785     History of Changes
Other Study ID Numbers: RTOG-0225
CDR0000269314
First Submitted: April 7, 2003
First Posted: April 9, 2003
Results First Submitted: October 8, 2014
Results First Posted: October 13, 2014
Last Update Posted: February 17, 2017