Clinical Trials /

Surgery in Treating Patients With Neuroblastoma

NCT00003122

Description:

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.

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Unknown status

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT00003122

Trial Eligibility

Document

Title

  • Brief Title: Surgery in Treating Patients With Neuroblastoma
  • Official Title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

Clinical Trial IDs

  • ORG STUDY ID: CDR0000065880
  • SECONDARY ID: SIOP-95-1
  • SECONDARY ID: EU-96053
  • NCT ID: NCT00003122

Conditions

  • Neuroblastoma

Purpose

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.

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.

Trial Arms

NameTypeDescriptionInterventions

Eligibility 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
Maximum Eligible Age:20 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and efficacy
Time Frame:
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Societe Internationale d'Oncologie Pediatrique

Trial Keywords

  • localized resectable neuroblastoma
  • localized unresectable neuroblastoma

Last Updated

August 26, 2013