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NCT00499616 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
A Phase 3 study of Neuroblastoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 464
- Enrollment target
- 20
- Study locations
NCT00499616 is a Phase 3 study of Neuroblastoma that has completed, run by Children's Oncology Group. The registered enrollment target is 464 participants, above the 234-participant average among 94 other Neuroblastoma trials with a reported enrollment target (98% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT00499616, a Phase 3 study of Neuroblastoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 464 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor can be surgically removed. It is not yet known what is the minimal amount of chemotherapy needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and prevent tumor recurrence or metastases. PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles administered and by allowing for up to 50% residual tumor volume for patients with localized disease.
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG cyclophosphamide
- DRUG etoposide
- DRUG doxorubicin hydrochloride
- DRUG topotecan hydrochloride
Study Locations (20)
California
- Southern California Permanente Medical Group - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- 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
- Childrens Hospital Los Angeles - Los Angeles
- Children's Hospital Central California - Madera
- Children's Hospital and Research Center Oakland - Oakland
- 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
- Kaiser Permanente Medical Center - Oakland - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Alabama
- UAB Comprehensive Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer 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
Colorado
- Children's Hospital Center for Cancer and Blood Disorders - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2007-10-08 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00499616
The ClinicalTrials.gov registry entry for NCT00499616 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 464 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 94 other Neuroblastoma trials with a reported enrollment target (98% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
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.
NCT00499616 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00499616 about?
NCT00499616 is a clinical study titled "Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma". RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like ...
What is the current status of trial NCT00499616?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 464 participants. The study started on 2007-10-08. Estimated completion is 2021-06-30.
What conditions does trial NCT00499616 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT00499616?
The interventions under investigation include: carboplatin (DRUG), cyclophosphamide (DRUG), etoposide (DRUG), doxorubicin hydrochloride (DRUG), topotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00499616?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00499616 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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