TriangleNCT04221945 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline and week 36
What was measured
The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.
Analysis population: Randomized participants who have at least 1 patient reported outcome (PRO) assessment for QLQ-C30 available and have received at least 1 dose of study medication.
Groups in this outcome
Chemoradiotherapy + Pembrolizumab
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
Chemoradiotherapy + Placebo for Pembrolizumab
Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
| Group | Source count |
|---|---|
| Chemoradiotherapy + Pembrolizumab | 503 |
| Chemoradiotherapy + Placebo for Pembrolizumab | 506 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiotherapy + Pembrolizumab | 7.51 | Not reported | 5.30 | 9.73 | Not reported |
| Chemoradiotherapy + Placebo for Pembrolizumab | 7.44 | Not reported | 5.23 | 9.66 | Not reported |
Source statistical analyses
- ci Lower Limit
- -2.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.80
- estimate Comment
- Pembrolizumab minus placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- Based on a cLDA model with the patient-reported outcome (PRO) scores as the response variable with covariates for treatment by study visit interaction, and stratified by planned type of EBRT.
- p Value
- 0.9593
- param Type
- Difference LS Means
- param Value
- 0.07
- statistical Method
- cLDA model
Complete source fields
- analyses
- ci Lower Limit
- -2.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.80
- estimate Comment
- Pembrolizumab minus placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- Based on a cLDA model with the patient-reported outcome (PRO) scores as the response variable with covariates for treatment by study visit interaction, and stratified by planned type of EBRT.
- p Value
- 0.9593
- param Type
- Difference LS Means
- param Value
- 0.07
- statistical Method
- cLDA model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.30
- upper Limit
- 9.73
- value
- 7.51
- group Id
- OG001
- lower Limit
- 5.23
- upper Limit
- 9.66
- value
- 7.44
- denoms
- counts
- group Id
- OG000
- value
- 503
- group Id
- OG001
- value
- 506
- units
- Participants
- description
- The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
- id
- OG000
- title
- Chemoradiotherapy + Pembrolizumab
- description
- Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
- id
- OG001
- title
- Chemoradiotherapy + Placebo for Pembrolizumab
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Randomized participants who have at least 1 patient reported outcome (PRO) assessment for QLQ-C30 available and have received at least 1 dose of study medication.
- reporting Status
- POSTED
- time Frame
- Baseline and week 36
- title
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice