TriangleNCT00122460 · OUTCOME
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- scores on a scale
- Interval / dispersion
- Standard Error
- Time frame
- at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007
What was measured
Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
Analysis population: Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab+chemotherapy/chemotherapy alone): Baseline: 121/106; Cycle3:87/67; Month6:48/22
Groups in this outcome
Cetuximab Plus Chemotherapy
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
Chemotherapy Alone
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
| Group | Source count |
|---|---|
| Cetuximab Plus Chemotherapy | 152 |
| Chemotherapy Alone | 139 |
Reported measurements
At baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab Plus Chemotherapy | 50.74 | 3.519 | Not reported | Not reported | Not reported |
| Chemotherapy Alone | 45.15 | 3.745 | Not reported | Not reported | Not reported |
At cycle 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab Plus Chemotherapy | 52.68 | 3.724 | Not reported | Not reported | Not reported |
| Chemotherapy Alone | 45.48 | 4.153 | Not reported | Not reported | Not reported |
Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab Plus Chemotherapy | 55.30 | 4.282 | Not reported | Not reported | Not reported |
| Chemotherapy Alone | 42.49 | 5.959 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.519
- value
- 50.74
- group Id
- OG001
- spread
- 3.745
- value
- 45.15
- title
- At baseline
- categories
- measurements
- group Id
- OG000
- spread
- 3.724
- value
- 52.68
- group Id
- OG001
- spread
- 4.153
- value
- 45.48
- title
- At cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 4.282
- value
- 55.30
- group Id
- OG001
- spread
- 5.959
- value
- 42.49
- title
- Month 6
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 139
- units
- Participants
- description
- Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
- dispersion Type
- Standard Error
- groups
- description
- Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
- id
- OG000
- title
- Cetuximab Plus Chemotherapy
- description
- All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
- id
- OG001
- title
- Chemotherapy Alone
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab+chemotherapy/chemotherapy alone): Baseline: 121/106; Cycle3:87/67; Month6:48/22
- reporting Status
- POSTED
- time Frame
- at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007
- title
- Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
- type
- SECONDARY
- unit Of Measure
- scores on a scale
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Preserved source evidence · Not medical advice