TriangleNCT01767194 · OUTCOME
Percentage of Randomized Patients Who Are Responders
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to the first 6 cycles of treatment
What was measured
The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= \>90% decrease of the disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= \>=30% decrease in the disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/Vanillylmandelic acid (VMA) may still be elevated.
Analysis population: Includes all eligible patients randomly assigned to Arm I or Arm II. Of the 19 participants randomized to Arm I, one was ineligible and not included in the analysis. Of the 54 participants assigned to Arm II, 1 was ineligible and 36 were non-randomly assigned, and not included in the analysis.
Groups in this outcome
Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)
CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV
Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
| Group | Source count |
|---|---|
| Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 18 |
| Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 5.6 | Not reported | 0.0 | 16.1 | Not reported |
| Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 52.9 | Not reported | 29.2 | 76.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 16.1
- value
- 5.6
- group Id
- OG001
- lower Limit
- 29.2
- upper Limit
- 76.7
- value
- 52.9
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 17
- units
- Participants
- description
- The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= \>90% decrease of the disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= \>=30% decrease in the disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/Vanillylmandelic acid (VMA) may still be elevated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV
- id
- OG000
- title
- Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)
- description
- Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
- id
- OG001
- title
- Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
- param Type
- NUMBER
- population Description
- Includes all eligible patients randomly assigned to Arm I or Arm II. Of the 19 participants randomized to Arm I, one was ineligible and not included in the analysis. Of the 54 participants assigned to Arm II, 1 was ineligible and 36 were non-randomly assigned, and not included in the analysis.
- reporting Status
- POSTED
- time Frame
- Up to the first 6 cycles of treatment
- title
- Percentage of Randomized Patients Who Are Responders
- type
- PRIMARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice