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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00068237
First received: September 10, 2003
Last updated: February 5, 2014
Last verified: February 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[units: participants]
  44  
Age  
[units: years]
Median ( Full Range )
  56.5  
  ( 42 to 74 )  
Gender  
[units: participants]
 
Female     8  
Male     36  



  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.   Safety Issue:   Yes

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

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

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

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.   Safety Issue:   No

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.   Safety Issue:   No


  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
Study First Received: September 10, 2003
Results First Received: October 29, 2013
Last Updated: February 5, 2014
Health Authority: United States: Federal Government