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NCT00003119 · ClinicalTrials.gov registry record · Phase 3
Surgery in Treating Children With Neuroblastoma
A Phase 3 study of Neuroblastoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 968
- Enrollment target
- 20
- Study locations
NCT00003119: Completed Phase 3 study of Neuroblastoma, sponsored by Children's Oncology Group.
NCT00003119 is a Phase 3 study of Neuroblastoma that has completed, run by Children's Oncology Group. The registered enrollment target is 968 participants, above the 229-participant average among 94 other Neuroblastoma trials with a reported enrollment target (323% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003119, a Phase 3 study of Neuroblastoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 968 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The 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 subgrou
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG cyclophosphamide
- BIOLOGICAL filgrastim
- DRUG doxorubicin hydrochloride
- BIOLOGICAL sargramostim
Study Locations (20)
California
- Southern California Permanente Medical Group - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Rebecca and John Moores UCSD Cancer Center - La Jolla
- Loma Linda University Cancer Institute at Loma Linda University Medical Center - Loma Linda
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center - Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA - Los Angeles
- Children's Hospital Central California - Madera
- Children's Hospital and Research Center at Oakland - Oakland
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center - Orange
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital at Stanford University Medical Center - Palo Alto
- Sutter Cancer Center - Sacramento
- University of California Davis Cancer Center - Sacramento
Alabama
- University of Alabama at Birmingham Comprehensive Cancer Center - Birmingham
- University of South Alabama Cancer Research Institute - Mobile
Arizona
- Phoenix Children's Hospital - Phoenix
- Arizona Cancer Center at University of Arizona Health Sciences Center - Tucson
Arkansas
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 968 participants |
| Start Date | 1998-03 |
| Est. Completion | 2006-03 |
| Phase | Phase 3 |
What the finished NCT00003119 record still lists
NCT00003119 is an interventional study that assigns participants to a tested intervention. The registered 968 participants enrollment target is mid-sized for trials with a published cap, above the 229-participant average among 94 other Neuroblastoma trials with a reported enrollment target (323% higher).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which carboplatin is the first listed.
NCT00003119 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00003119 about?
NCT00003119 is a clinical study titled "Surgery in Treating Children With Neuroblastoma". 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.
What is the current status of trial NCT00003119?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 968 participants. The study started on 1998-03. Estimated completion is 2006-03.
What conditions does trial NCT00003119 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT00003119?
The interventions under investigation include: carboplatin (DRUG), cyclophosphamide (DRUG), filgrastim (BIOLOGICAL), doxorubicin hydrochloride (DRUG), sargramostim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00003119?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00003119 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00003119's enrollment target sits among peer trials
968 6th of 94 higher than 89 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
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-
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-
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
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-
MCT for the Harvard/UCSF ROBIN Center
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