TriangleNCT01502410 · OUTCOME
Progression-free Survival According to RECIST Version 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Six months after enrollment
What was measured
Percent probability of being progression free six months following enrollment. Progression-free interval (PFI) will be calculated as the date of enrollment until the end PFI date, where that date is calculated as the date of disease progression, date of death, date of removal of all tumors by surgery or last patient contact, whichever occurs first.
Analysis population: All eligible patients are included in this analysis for both Rhabdomyosarcoma and Wilms Tumor. However, there were no accruals on the disease arms for Hepatocellular carcinoma and Papillary Thyroid carcinoma and were not included in this analysis.
Groups in this outcome
Group 1 Relapsed/Refractory Rhabdomyosarcoma
Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
Group 2 Relapsed/Refractory Wilms Tumor
Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
| Group | Source count |
|---|---|
| Group 1 Relapsed/Refractory Rhabdomyosarcoma | 10 |
| Group 2 Relapsed/Refractory Wilms Tumor | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 Relapsed/Refractory Rhabdomyosarcoma | 10 | Not reported | 0.57 | 36 | Not reported |
| Group 2 Relapsed/Refractory Wilms Tumor | 23 | Not reported | 3.5 | 52 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.57
- upper Limit
- 36
- value
- 10
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- 52
- value
- 23
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Percent probability of being progression free six months following enrollment. Progression-free interval (PFI) will be calculated as the date of enrollment until the end PFI date, where that date is calculated as the date of disease progression, date of death, date of removal of all tumors by surgery or last patient contact, whichever occurs first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
- id
- OG000
- title
- Group 1 Relapsed/Refractory Rhabdomyosarcoma
- description
- Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
- id
- OG001
- title
- Group 2 Relapsed/Refractory Wilms Tumor
- param Type
- NUMBER
- population Description
- All eligible patients are included in this analysis for both Rhabdomyosarcoma and Wilms Tumor. However, there were no accruals on the disease arms for Hepatocellular carcinoma and Papillary Thyroid carcinoma and were not included in this analysis.
- reporting Status
- POSTED
- time Frame
- Six months after enrollment
- title
- Progression-free Survival According to RECIST Version 1.1
- type
- SECONDARY
- unit Of Measure
- percentage of probability
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice