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Sponsored by: |
Societe Internationale d'Oncologie Pediatrique |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003122 |
RATIONALE: Surgery may be an effective treatment for neuroblastoma.
PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Procedure: surgical procedure |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma |
Estimated Enrollment: | 210 |
Study Start Date: | December 1994 |
OBJECTIVES:
OUTLINE: Patients with localized resectable tumors undergo surgery. Postoperative evaluations are performed 30 days following surgery. Study patients with stage I (without N-myc amplification) tumors and trial patients with stage II tumors receive no further therapy.
Study patients (except stage I patients) receive surgery and/or chemotherapy according to other protocols as necessary for disease progression or relapse.
Patients are followed every 3 months for the first year, then every 4 and 6 months for the second and third year respectively, then yearly for 5 years.
PROJECTED ACCRUAL: This study will accrue 140 stage II patients for the trial portion at a rate of 40 per year over 3.5 years. At least 70 more patients will be accrued for the study portion.
Ages Eligible for Study: | up to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Study: Histologically proven neuroblastoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Jean Marie Michon, MD | Institut Curie Hopital |
Study ID Numbers: | CDR0000065880, SIOP-95-1, EU-96053 |
Study First Received: | November 1, 1999 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00003122 History of Changes |
Health Authority: | Unspecified |
localized resectable neuroblastoma localized unresectable neuroblastoma |
Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Neuroectodermal Tumors, Primitive, Peripheral Neuroblastoma Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neuroblastoma Neoplasms, Glandular and Epithelial |