Comparison · NCT00311584-e07714b4
Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) vs Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide): Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) vs Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide): Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR). Trial comparisons, record NCT00311584-e07714b4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00311584-e07714b4
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.185 | 0.0818 | 0.367 | wilson | |
| Risk in group 2 | 0.107 | 0.0371 | 0.272 | wilson | |
| Risk difference, group 1 minus group 2 | 0.078 | -0.117 | 0.273 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.73 | 0.457 | 6.54 | log | |
| Odds ratio, group 1 over group 2 | 1.89 | 0.405 | 8.85 | log | |
Number needed to treat, for one more participant with the outcome on Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) than on Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 12.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV | 5 | 27 | OG000 |
| Group 2 | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV | 3 | 28 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
- Description
The patient's best overall response obtained during Reporting Periods 1 and 2 will be scored as best response. Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response).
- Time frame
- up to 6 courses of therapy, or about 6 months
- Population
Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.
Source ClinicalTrials.gov
Trial
- Title
- Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma
- NCT number
- NCT00311584
- Phases
- PHASE2
- Conditions
- Neuroblastoma
- Interventions
- irinotecan hydrochloride, temozolomide
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2014-01-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00311584?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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