TriangleNCT04607421 · OUTCOME
Phase 3: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients - 30 Item Core Questionnaire (EORTC QLQC30) Global Health Status/Quality of Life Scores (QoL) at Baseline and Week 72
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Week 72
What was measured
EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These included five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Global health status/QoL scale ranged from 0 to 100; the higher score represents better level of functioning. In this outcome measure, global health status/QoL scores are presented.
Analysis population: The FAS for Phase 3 included all participants who were randomized in the Phase 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.
Groups in this outcome
Phase 3: Arm A [EC]
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
Phase 3: Arm B [EC + mFOLFOX6]
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
| Group | Source count |
|---|---|
| Phase 3: Arm A [EC] | 134 |
| Phase 3: Arm B [EC + mFOLFOX6] | 201 |
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 181 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| Phase 3: Arm A [EC] | 134 |
| Phase 3: Arm B [EC + mFOLFOX6] | 201 |
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 181 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 3: Arm A [EC] | 63.0 | 21.64 | Not reported | Not reported | Not reported |
| Phase 3: Arm B [EC + mFOLFOX6] | 67.1 | 21.65 | Not reported | Not reported | Not reported |
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 66.8 | 21.43 | Not reported | Not reported | Not reported |
Week 72
| Group | Source count |
|---|---|
| Phase 3: Arm A [EC] | 24 |
| Phase 3: Arm B [EC + mFOLFOX6] | 59 |
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 3: Arm A [EC] | 75.3 | 14.64 | Not reported | Not reported | Not reported |
| Phase 3: Arm B [EC + mFOLFOX6] | 71.3 | 18.52 | Not reported | Not reported | Not reported |
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 73.3 | 16.57 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.64
- value
- 63.0
- group Id
- OG001
- spread
- 21.65
- value
- 67.1
- group Id
- OG002
- spread
- 21.43
- value
- 66.8
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 201
- group Id
- OG002
- value
- 181
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 14.64
- value
- 75.3
- group Id
- OG001
- spread
- 18.52
- value
- 71.3
- group Id
- OG002
- spread
- 16.57
- value
- 73.3
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 59
- group Id
- OG002
- value
- 10
- units
- Participants
- title
- Week 72
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 201
- group Id
- OG002
- value
- 181
- units
- Participants
- description
- EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These included five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Global health status/QoL scale ranged from 0 to 100; the higher score represents better level of functioning. In this outcome measure, global health status/QoL scores are presented.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG000
- title
- Phase 3: Arm A [EC]
- description
- Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG001
- title
- Phase 3: Arm B [EC + mFOLFOX6]
- description
- Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
- id
- OG002
- title
- Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
- param Type
- MEAN
- population Description
- The FAS for Phase 3 included all participants who were randomized in the Phase 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 72
- title
- Phase 3: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients - 30 Item Core Questionnaire (EORTC QLQC30) Global Health Status/Quality of Life Scores (QoL) at Baseline and Week 72
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice