TriangleNCT00939627 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- On-study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)
What was measured
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Analysis population: All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known alive date.
Groups in this outcome
Arm A - Cetuximab
Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Arm B - Cetuximab and Sorafenib Tosylate
Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
| Group | Source count |
|---|---|
| Arm A - Cetuximab | 26 |
| Arm B - Cetuximab and Sorafenib Tosylate | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A - Cetuximab | 3 | Not reported | 1.9 | 5.0 | Not reported |
| Arm B - Cetuximab and Sorafenib Tosylate | 3.2 | Not reported | 1.8 | 4.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 5.0
- value
- 3
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 4.2
- value
- 3.2
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 26
- units
- Participants
- description
- Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
- id
- OG000
- title
- Arm A - Cetuximab
- description
- Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
- id
- OG001
- title
- Arm B - Cetuximab and Sorafenib Tosylate
- param Type
- MEDIAN
- population Description
- All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known alive date.
- reporting Status
- POSTED
- time Frame
- On-study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice