NCT01898494 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 38
- group Id
- BG001
- value
- 100
- group Id
- BG002
- value
- 108
- group Id
- BG003
- value
- 113
- group Id
- BG004
- value
- 359
- units
- Participants
- groups
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation. Transoral surgery: Undergo transoral surgical resection
- id
- BG000
- title
- Arm S (Surgery) Then Arm A (Low Risk, Observation)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks. Transoral surgery: Undergo transoral surgical resection intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT
- id
- BG001
- title
- Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks. Transoral surgery: Undergo transoral surgical resection intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT
- id
- BG002
- title
- Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes or carboplatin over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy. Transoral surgery: Undergo transoral surgical resection intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT cisplatin: Given IV carboplatin: Given IV
- id
- BG003
- title
- Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 46
- upper Limit
- 76
- value
- 61
- group Id
- BG001
- lower Limit
- 42
- upper Limit
- 75
- value
- 59
- group Id
- BG002
- lower Limit
- 40
- upper Limit
- 77
- value
- 57
- group Id
- BG003
- lower Limit
- 37
- upper Limit
- 80
- value
- 58
- group Id
- BG004
- lower Limit
- 37
- upper Limit
- 80
- value
- 58
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 8
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 16
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 40
- title
- Female
- measurements
- group Id
- BG000
- value
- 30
- group Id
- BG001
- value
- 95
- group Id
- BG002
- value
- 92
- group Id
- BG003
- value
- 102
- group Id
- BG004
- value
- 319
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 11
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 90
- group Id
- BG002
- value
- 98
- group Id
- BG003
- value
- 100
- group Id
- BG004
- value
- 324
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 24
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 9
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 35
- group Id
- BG001
- value
- 93
- group Id
- BG002
- value
- 97
- group Id
- BG003
- value
- 106
- group Id
- BG004
- value
- 331
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 18
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- Eligible and treated patients
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 38
- group Id
- BG001
- value
- 100
- group Id
- BG002
- value
- 108
- group Id
- BG003
- value
- 113
- group Id
- BG004
- value
- 359
- units
- Participants
- groups
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation. Transoral surgery: Undergo transoral surgical resection
- id
- BG000
- title
- Arm S (Surgery) Then Arm A (Low Risk, Observation)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks. Transoral surgery: Undergo transoral surgical resection intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT
- id
- BG001
- title
- Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks. Transoral surgery: Undergo transoral surgical resection intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT
- id
- BG002
- title
- Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes or carboplatin over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy. Transoral surgery: Undergo transoral surgical resection intensity-modulated radiation therapy: Undergo standard-dose or low-dose IMRT cisplatin: Given IV carboplatin: Given IV
- id
- BG003
- title
- Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 46
- upper Limit
- 76
- value
- 61
- group Id
- BG001
- lower Limit
- 42
- upper Limit
- 75
- value
- 59
- group Id
- BG002
- lower Limit
- 40
- upper Limit
- 77
- value
- 57
- group Id
- BG003
- lower Limit
- 37
- upper Limit
- 80
- value
- 58
- group Id
- BG004
- lower Limit
- 37
- upper Limit
- 80
- value
- 58
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 8
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 16
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 40
- title
- Female
- measurements
- group Id
- BG000
- value
- 30
- group Id
- BG001
- value
- 95
- group Id
- BG002
- value
- 92
- group Id
- BG003
- value
- 102
- group Id
- BG004
- value
- 319
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 11
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 90
- group Id
- BG002
- value
- 98
- group Id
- BG003
- value
- 100
- group Id
- BG004
- value
- 324
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 24
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 9
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 35
- group Id
- BG001
- value
- 93
- group Id
- BG002
- value
- 97
- group Id
- BG003
- value
- 106
- group Id
- BG004
- value
- 331
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 18
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- Eligible and treated patients
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