TriangleNCT01502410 · OUTCOME
Objective Response by RECIST Criteria v 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- 6 cycles (168 days)
What was measured
Response rates will be calculated as the number of evaluable patients who are responders. Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Analysis population: Only Rhabdomyosarcoma and Wilms Tumor patients are included in this analysis as there were no accruals on Hepatocellular carcinoma and no accruals on Thyroid carcinoma.
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
Non-Responder
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 Relapsed/Refractory Rhabdomyosarcoma | 10 | Not reported | Not reported | Not reported | Not reported |
| Group 2 Relapsed/Refractory Wilms Tumor | 10 | Not reported | Not reported | Not reported | Not reported |
Responder
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 Relapsed/Refractory Rhabdomyosarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Group 2 Relapsed/Refractory Wilms Tumor | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- title
- Non-Responder
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Responder
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Response rates will be calculated as the number of evaluable patients who are responders. Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- 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
- Only Rhabdomyosarcoma and Wilms Tumor patients are included in this analysis as there were no accruals on Hepatocellular carcinoma and no accruals on Thyroid carcinoma.
- reporting Status
- POSTED
- time Frame
- 6 cycles (168 days)
- title
- Objective Response by RECIST Criteria v 1.1
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice