Surgery in Treating Children With Neuroblastoma
|ClinicalTrials.gov Identifier: NCT00003119|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 13, 2017
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma.
PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Biological: filgrastim Biological: sargramostim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||968 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study|
|Study Start Date :||March 1998|
|Primary Completion Date :||March 2006|
|Study Completion Date :||March 2006|
|Experimental: Treatment 1 - Asymptomatic - no immediate chemotherapy||Procedure: conventional surgery Radiation: radiation therapy|
|Experimental: Symptomatic - immediate chemotherapy||Biological: filgrastim Biological: sargramostim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy|
- Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery aloneThe primary objective is to estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone. Under the assumption that about 90% of the low risk 2A/2B patients will be asymptomatic, and 10% of these will be lost to follow up, the projected sample size will enable estimation of the survival rate with a standard error less than .03. This sample size will also provide sufficient power for the sequential monitoring plan (see below) for this subgroup of patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003119
Show 235 Study Locations
|Study Chair:||Douglas R. Strother, MD||Alberta Children's Hospital|