Trial Outcomes & Findings for Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer (NCT NCT00352118)
NCT ID: NCT00352118
Last Updated: 2017-12-28
Results Overview
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
TERMINATED
PHASE2
4 participants
at 12 months
2017-12-28
Participant Flow
Patients were recruited from the Masonic Cancer Center physicians' clinics.
Participant milestones
| Measure |
Chemotherapy + Low Dose Radiation
Patients receiving combination chemotherapy plus low dose radiation
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Chemotherapy + Low Dose Radiation
Patients receiving combination chemotherapy plus low dose radiation
|
|---|---|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Chemotherapy + Low Dose Radiation
n=4 Participants
Patients receiving combination chemotherapy plus low dose radiation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 12 monthsPopulation: All patients were non-evaluable - did not receive radiation dose per protocol.
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between date of registration to date of first treatment failure or death.Population: All patients were non-evaluable - did not receive radiation dose per protocol.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between date of registration to date of death.Population: All patients were non-evaluable - did not receive radiation dose per protocol.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Date of Registration to Date of First Treatment Failure or DeathPopulation: All patients were non-evaluable - did not receive radiation dose per protocol.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Number of Days from Complete or Partial Response to First Date of Recurrence or ProgressionPopulation: All patients were non-evaluable - did not receive radiation dose per protocol.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.Population: All patients were non-evaluable - did not receive radiation dose per protocol.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 yearPopulation: All patients were non-evaluable - did not receive radiation dose per protocol.
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
Outcome measures
Outcome data not reported
Adverse Events
Chemotherapy + Low Dose Radiation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Frank Ondrey, M.D.
Masonic Cancer Center, University of Minnesota
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place