ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

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.
ClinicalTrials.gov Identifier: NCT00352118
Recruitment Status : Terminated (Low dose radiation treatment was not appropriate for these patients.)
First Posted : July 14, 2006
Results First Posted : July 21, 2009
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Biological: filgrastim
Biological: pegfilgrastim
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil
Procedure: conventional surgery
Radiation: 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
Patients were recruited from the Masonic Cancer Center physicians' clinics.

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
Chemotherapy + Low Dose Radiation Patients receiving combination chemotherapy plus low dose radiation

Participant Flow:   Overall Study
    Chemotherapy + Low Dose Radiation
STARTED   4 
COMPLETED   0 
NOT COMPLETED   4 
Physician Decision                4 



  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.
No text entered.

Reporting Groups
  Description
Chemotherapy + Low Dose Radiation Patients receiving combination chemotherapy plus low dose radiation

Baseline Measures
   Chemotherapy + Low Dose Radiation 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      2  50.0% 
>=65 years      2  50.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.8  (7.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  25.0% 
Male      3  75.0% 
Region of Enrollment 
[Units: Participants]
 
United States   4 


  Outcome Measures

1.  Primary:   Number of Patients With Feeding Tube Dependency   [ Time Frame: at 12 months ]

Measure Type Primary
Measure Title Number of Patients With Feeding Tube Dependency
Measure Description All patients were non-evaluable and study was terminated early. There is no measure of outcome.
Time Frame at 12 months  

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 patients were non-evaluable - did not receive radiation dose per protocol.

Reporting Groups
  Description
Chemotherapy + Low Dose Radiation Patients receiving combination chemotherapy plus low dose radiation

Measured Values
   Chemotherapy + Low Dose Radiation 
Participants Analyzed   0 
Number of Patients With Feeding Tube Dependency    

No statistical analysis provided for Number of Patients With Feeding Tube Dependency



2.  Secondary:   Number of Days With Progression-free Survival   [ Time Frame: Between date of registration to date of first treatment failure or death. ]

Measure Type Secondary
Measure Title Number of Days With Progression-free Survival
Measure Description All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Time Frame Between date of registration to date of first treatment failure or death.  

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 patients were non-evaluable - did not receive radiation dose per protocol.

Reporting Groups
  Description
Chemotherapy + Low Dose Radiation Patients receiving combination chemotherapy plus low dose radiation

Measured Values
   Chemotherapy + Low Dose Radiation 
Participants Analyzed   0 
Number of Days With Progression-free Survival    

No statistical analysis provided for Number of Days With Progression-free Survival



3.  Secondary:   Number of Days - Overall Survival   [ Time Frame: Between date of registration to date of death. ]

Measure Type Secondary
Measure Title Number of Days - Overall Survival
Measure Description All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Time Frame Between date of registration to date of death.  

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 patients were non-evaluable - did not receive radiation dose per protocol.

Reporting Groups
  Description
Chemotherapy + Low Dose Radiation Patients receiving combination chemotherapy plus low dose radiation

Measured Values
   Chemotherapy + Low Dose Radiation 
Participants Analyzed   0 
Number of Days - Overall Survival    

No statistical analysis provided for Number of Days - Overall Survival



4.  Secondary:   Number of Days With Disease Free Survival   [ Time Frame: From Date of Registration to Date of First Treatment Failure or Death ]

Measure Type Secondary
Measure Title Number of Days With Disease Free Survival
Measure Description All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.
Time Frame From Date of Registration to Date of First Treatment Failure or Death  

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 patients were non-evaluable - did not receive radiation dose per protocol.

Reporting Groups
  Description
Chemotherapy + Low Dose Radiation Patients receiving combination chemotherapy plus low dose radiation

Measured Values
   Chemotherapy + Low Dose Radiation 
Participants Analyzed   0 
Number of Days With Disease Free Survival    

No statistical analysis provided for Number of Days With Disease Free Survival



5.  Secondary:   Time to Treatment Failure   [ Time Frame: Number of Days from Complete or Partial Response to First Date of Recurrence or Progression ]

Measure Type Secondary
Measure Title Time to Treatment Failure
Measure Description All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.
Time Frame Number of Days from Complete or Partial Response to First Date of Recurrence or Progression  

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 patients were non-evaluable - did not receive radiation dose per protocol.

Reporting Groups
  Description
Chemotherapy + Low Dose Radiation Patients receiving combination chemotherapy plus low dose radiation

Measured Values
   Chemotherapy + Low Dose Radiation 
Participants Analyzed   0 
Time to Treatment Failure    

No statistical analysis provided for Time to Treatment Failure



6.  Secondary:   Swallowing Ability - Quality of Life Scores   [ Time Frame: Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2. ]

Measure Type Secondary
Measure Title Swallowing Ability - Quality of Life Scores
Measure Description All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).
Time Frame Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.  

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 patients were non-evaluable - did not receive radiation dose per protocol.

Reporting Groups
  Description
Chemotherapy + Low Dose Radiation Patients receiving combination chemotherapy plus low dose radiation

Measured Values
   Chemotherapy + Low Dose Radiation 
Participants Analyzed   0 
Swallowing Ability - Quality of Life Scores    

No statistical analysis provided for Swallowing Ability - Quality of Life Scores



7.  Secondary:   Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire   [ Time Frame: baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year ]

Measure Type Secondary
Measure Title Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire
Measure Description All patients were non-evaluable and study was terminated early. There is no measure of outcome.
Time Frame baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year  

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 patients were non-evaluable - did not receive radiation dose per protocol.

Reporting Groups
  Description
Chemotherapy + Low Dose Radiation Patients receiving combination chemotherapy plus low dose radiation

Measured Values
   Chemotherapy + Low Dose Radiation 
Participants Analyzed   0 
Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire    

No statistical analysis provided for Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
All 4 patients received high dose radiation (66-70 Gy). The radiation oncologist on this study deemed low dose radiation treatment was not appropriate for these patients. Therefore, the study participants are not evaluable.


  More Information

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


Results Point of Contact:  
Name/Title: Frank Ondrey, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-625-3200
e-mail: ondre002@umn.edu



Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00352118     History of Changes
Other Study ID Numbers: 2005LS012
UMN-0502M67486
First Submitted: July 13, 2006
First Posted: July 14, 2006
Results First Submitted: June 2, 2009
Results First Posted: July 21, 2009
Last Update Posted: December 28, 2017