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Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00068237
First Posted: September 11, 2003
Last Update Posted: February 17, 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):
Radiation Therapy Oncology Group
Results First Submitted: October 29, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Head and Neck Cancer
Radiation Toxicity
Xerostomia
Interventions: Procedure: Surgery for the primary and neck nodes
Procedure: Submandibular salivary gland transfer
Radiation: Post-operative 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
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Reporting Groups
  Description
Surgery and Salivary Gland Transfer and Radiation Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.

Participant Flow:   Overall Study
    Surgery and Salivary Gland Transfer and Radiation
STARTED   49 
COMPLETED   44 [1] 
NOT COMPLETED   5 
Ineligible                3 
No protocol treatment received                2 
[1] Subjects contributing data to the primary analysis are considered to have completed the study.



  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 eligible patients who started study treatment.

Reporting Groups
  Description
Surgery and Salivary Gland Transfer and Radiation Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.

Baseline Measures
   Surgery and Salivary Gland Transfer and Radiation 
Overall Participants Analyzed 
[Units: Participants]
 44 
Age 
[Units: Years]
Median (Full Range)
 56.5 
 (42 to 74) 
Gender 
[Units: Participants]
Count of Participants
 
Female      8  18.2% 
Male      36  81.8% 


  Outcome Measures

1.  Primary:   Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"   [ Time Frame: At the time of the submandibular salivary gland transfer ]

2.  Secondary:   Rate of Acute Xerostomia   [ Time Frame: From start of treatment to 90 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Salivary Scan Evaluation   [ Time Frame: From start of treatment to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Quality of Life   [ Time Frame: From registration to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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

6.  Secondary:   Disease-free Survival   [ Time Frame: From registration to date of failure (local or regional persistence/relapse or distant metastasis or second primary tumor or death) or last follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Overall Survival   [ Time Frame: From registration to date of death or last follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
e-mail: wseiferheld@acr.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00068237     History of Changes
Other Study ID Numbers: RTOG-0244
CDR0000287213
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: October 29, 2013
Results First Posted: January 31, 2014
Last Update Posted: February 17, 2017