A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) in High Risk Abdominal Neuroblastoma
Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma
treatment regimen will be eligible to enroll prior to surgical resection of the primary
tumor. Following implantation of fiducial markers within the tumor bed and autologous
hematopoietic rescue, patients will begin the planning process for abdominal irradiation;
this requires multiple baseline studies, including computed tomography (CT), magnetic
resonance imaging (MRI), renal scintigraphy, and bloodwork. Most of these tests will be
repeated on a varying schedule over the five year follow-up period of the protocol, in order
to evaluate the impact of conformal radiotherapy on intra-abdominal tissues.
Intensity modulated radiation therapy (IMRT) delivery will follow current conventional
volume-targeting guidelines, however, appropriate application within the abdomen will be
determined by ascertaining intra-abdominal organ motion and the potential for reducing
normal tissue dose, while simultaneously increasing dose delivered to target tissues,
particularly when dose escalation for gross residual disease is required. Concurrent
neuro-hormonal tests, cytokine analyses, functional and morphologic imaging will generate
novel data describing the acute and chronic effects of radiotherapy within the abdomen.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Local-regional failure rate.
Measurement of time from date of start of radiation therapy to date of local-regional failure or last follow-up (day).
8 years (6 year accrual +2 year follow-up)
Atmaram S Pai-Panandiker, MD
St. Jude Children's Research Hospital
United States: Institutional Review Board
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