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Surgery in Treating Patients With Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003122
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Neuroblastoma Procedure: surgical procedure Phase 2

Detailed Description:

OBJECTIVES:

  • Evaluate the safety and efficacy of surgical treatment alone for stage II neuroblastoma without N-myc amplification (NMA).
  • Describe predictive factors of relapse and survival for stages I and II neuroblastoma without NMA treated by surgery alone.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Primary Purpose: Treatment
Official Title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
Study Start Date : December 1994

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety and efficacy
  2. Predictive factors of relapse and survival

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage IIA and IIB neuroblastoma without amplification of the N-myc oncogene

  • Study: Histologically proven neuroblastoma

    • Stage I
    • Stage II with amplified N-myc
    • Stage II without evaluation of N-myc
    • Stage II with symptomatic spinal cord compression
    • Stage III
  • No metastases diagnosed within 1 month of study

PATIENT CHARACTERISTICS:

Age:

  • 20 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy
  • No adjuvant chemotherapy planned

Endocrine therapy:

  • Prior use of steroids allowed

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003122


Locations
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Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
Investigators
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Study Chair: Jean Marie Michon, MD Institut Curie
More Information
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ClinicalTrials.gov Identifier: NCT00003122    
Other Study ID Numbers: CDR0000065880
SIOP-95-1
EU-96053
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: July 2007
Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
localized unresectable neuroblastoma
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue