NCT01302834 · OUTCOME
EuroQol Five Dimension Scale 3-level Version (EQ-5D-3L) Index Score Change From Baseline
Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer · Source last updated 2026-07-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Basline, end of treatment (6-7 weeks), and 3, 6, and 12 months from end of treatment.
What was measured
The EQ-5D-3L index score measures health-related quality of life using five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three levels of severity (1 = no problems, 2 = moderate problems, 3 = extreme problems). Responses across the five items are combined and transformed into a single utility (index) score. Possible scores range from 0 to 1, with higher scores indicating a better outcome. The change score was calculated as the postbaseline value minus the baseline value. A negative change reflects decline at the postbaseline timepoint and a positive change reflects improvement at the postbaseline timepoint.
Analysis population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data at baseline and at least one postbaseline timepoint.
Groups in this outcome
IMRT + Cisplatin
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin
Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT
IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
IMRT + Cetuximab
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab
Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT + Cisplatin | 128 |
|---|
| IMRT + Cetuximab | 119 |
|---|
Reported measurements
End of treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT + Cisplatin | 95 |
|---|
| IMRT + Cetuximab | 87 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IMRT + Cisplatin | -0.15 | 0.20 | Not reported | Not reported | Not reported |
|---|
| IMRT + Cetuximab | -0.13 | 0.21 | Not reported | Not reported | Not reported |
|---|
3 months from end of treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT + Cisplatin | 91 |
|---|
| IMRT + Cetuximab | 84 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IMRT + Cisplatin | -0.02 | 0.15 | Not reported | Not reported | Not reported |
|---|
| IMRT + Cetuximab | -0.01 | 0.18 | Not reported | Not reported | Not reported |
|---|
6 months from end of treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT + Cisplatin | 87 |
|---|
| IMRT + Cetuximab | 83 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IMRT + Cisplatin | 0.00 | 0.15 | Not reported | Not reported | Not reported |
|---|
| IMRT + Cetuximab | 0.03 | 0.15 | Not reported | Not reported | Not reported |
|---|
12 months from end of treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| IMRT + Cisplatin | 79 |
|---|
| IMRT + Cetuximab | 82 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IMRT + Cisplatin | 0.03 | 0.15 | Not reported | Not reported | Not reported |
|---|
| IMRT + Cetuximab | 0.03 | 0.18 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- anticipated Posting Date
- 2026-06
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.20
- value
- -0.15
- group Id
- OG001
- spread
- 0.21
- value
- -0.13
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 87
- units
- Participants
- title
- End of treatment
- categories
- measurements
- group Id
- OG000
- spread
- 0.15
- value
- -0.02
- group Id
- OG001
- spread
- 0.18
- value
- -0.01
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 84
- units
- Participants
- title
- 3 months from end of treatment
- categories
- measurements
- group Id
- OG000
- spread
- 0.15
- value
- 0.00
- group Id
- OG001
- spread
- 0.15
- value
- 0.03
- denoms
- counts
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 83
- units
- Participants
- title
- 6 months from end of treatment
- categories
- measurements
- group Id
- OG000
- spread
- 0.15
- value
- 0.03
- group Id
- OG001
- spread
- 0.18
- value
- 0.03
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 82
- units
- Participants
- title
- 12 months from end of treatment
- denoms
- counts
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 119
- units
- Participants
- description
- The EQ-5D-3L index score measures health-related quality of life using five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three levels of severity (1 = no problems, 2 = moderate problems, 3 = extreme problems). Responses across the five items are combined and transformed into a single utility (index) score. Possible scores range from 0 to 1, with higher scores indicating a better outcome. The change score was calculated as the postbaseline value minus the baseline value. A negative change reflects decline at the postbaseline timepoint and a positive change reflects improvement at the postbaseline timepoint.
- dispersion Type
- Standard Error
- groups
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin
Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT
IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG000
- title
- IMRT + Cisplatin
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab
Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG001
- title
- IMRT + Cetuximab
- param Type
- MEAN
- population Description
- Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data at baseline and at least one postbaseline timepoint.
- reporting Status
- POSTED
- time Frame
- Basline, end of treatment (6-7 weeks), and 3, 6, and 12 months from end of treatment.
- title
- EuroQol Five Dimension Scale 3-level Version (EQ-5D-3L) Index Score Change From Baseline
- type
- SECONDARY
- unit Of Measure
- score on a scale
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