logo Hematology/Oncology Research Studies: Open for Enrollment Date: 12/12/18

Category: NEURO-ONCOLOGY

Clinical/Molecular Risk-Tailored Intensive, Compressed Induction Chemotherapy Followed by Consolidation Randomization To Single-Cycle or 3 Tandem Cycles of Marrow-Ablative Chemo with Hematopoietic Progenitor Cell Rescue

NCT#/Phase: NCT02875314
Phase 4
IRB#: 2016-063
Description: This prospective randomized clinical trial will evaluate whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.
Inclusion: Individuals who are < 10 years of age with new diagnosis medulloblastoma (non-Wnt and non-Shh sub-groups) or other CNS embryonal tumors.
Enrollment Status: Open for enrollment
Sponsor: Next Consortium, Nationwide Children's
Principal Investigator(s): Joseph Torkildson, MD
Contact(s): Joseph Torkildson, MD

Study Link: https://clinicaltrials.gov/ct2/show/NCT02875314

UCSF Benioff Children's Hospital Oakland • 747 52nd Street, Oakland, California 94609 &bull Phone: (510) 428-3000