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

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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
Enrollment 4
Recruitment Details Patients were recruited from the Masonic Cancer Center physicians' clinics.
Pre-assignment Details  
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description Patients receiving combination chemotherapy plus low dose radiation
Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Physician Decision             4
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description Patients receiving combination chemotherapy plus low dose radiation
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  50.0%
>=65 years
2
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
62.8  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Number of Patients With Feeding Tube Dependency
Hide Description All patients were non-evaluable and study was terminated early. There is no measure of outcome.
Time Frame at 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were non-evaluable - did not receive radiation dose per protocol.
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description:
Patients receiving combination chemotherapy plus low dose radiation
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Days With Progression-free Survival
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were non-evaluable - did not receive radiation dose per protocol.
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description:
Patients receiving combination chemotherapy plus low dose radiation
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Days - Overall Survival
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were non-evaluable - did not receive radiation dose per protocol.
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description:
Patients receiving combination chemotherapy plus low dose radiation
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Days With Disease Free Survival
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were non-evaluable - did not receive radiation dose per protocol.
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description:
Patients receiving combination chemotherapy plus low dose radiation
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Treatment Failure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were non-evaluable - did not receive radiation dose per protocol.
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description:
Patients receiving combination chemotherapy plus low dose radiation
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Swallowing Ability - Quality of Life Scores
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were non-evaluable - did not receive radiation dose per protocol.
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description:
Patients receiving combination chemotherapy plus low dose radiation
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were non-evaluable - did not receive radiation dose per protocol.
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description:
Patients receiving combination chemotherapy plus low dose radiation
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy + Low Dose Radiation
Hide Arm/Group Description Patients receiving combination chemotherapy plus low dose radiation
All-Cause Mortality
Chemotherapy + Low Dose Radiation
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy + Low Dose Radiation
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy + Low Dose Radiation
Affected / at Risk (%)
Total   0/4 (0.00%) 
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.
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
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