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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003119 |
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 | Intervention | Phase |
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Neuroblastoma |
Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: sargramostim Procedure: adjuvant therapy Procedure: conventional surgery Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study |
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven low-risk neuroblastoma (excluding ganglioneuroma)
Immediate chemotherapy allowed prior to biopsy for patients with intradural extension and/or emergent paresis if biopsy performed within 96 hours
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Douglas R. Strother, MD | Alberta Children's Hospital |
Study ID Numbers: | CDR0000065874, COG-P9641, POG-P9641, CCG-P9641 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003119 |
Health Authority: | United States: Federal Government |
localized resectable neuroblastoma stage 4S neuroblastoma |
Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carboplatin Cyclophosphamide |
Etoposide phosphate Etoposide Doxorubicin Neuroectodermal Tumors, Primitive, Peripheral Neuroblastoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Alkylating Agents |