At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
Cycles N8, N5 and N6 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma
In Brief
A Phase 3 clinical trial evaluating Cycles N8, N5 and N6 and Cycles N5 and N6 for Neuroblastoma. Completed, enrolled 360 participants across 1 site.
Detailed Summary
Improvement of event free survival of high-risk neuroblastoma patients by introduction of two additional topotecan containing chemotherapy cycles into the multimodal standard treatment (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated, and consolidation therapy).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroblastoma
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
Primary CompletionDec 2016
First PostedFeb 2017
TodayJul 2026
First PostedFeb 3, 2017
Enrollment StartJan 1, 2007
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 9.4 years ago
Interventions
Cycles N8, N5 and N6drug
two chemotherapy cycles N8 followed by standard arm therapy
Cycles N5 and N6drug
Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin