Surgery in Treating Patients With Neuroblastoma | Recruiting
Surgery in Treating Patients With Neuroblastoma
Health Conditions
  • Neuroblastoma
Recruiting
Recruitment Status
NCT00003122
Primary Trial ID Number
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.
Primary Outcome Measures
  • Safety and efficacy; null; Predictive factors of relapse and survival; null
Secondary Outcome Measures
    Sorry, this information is not available
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
Austria; France; Ireland; Italy; Netherlands; Spain; Switzerland; United Kingdom
Participant Sex
Both
Participant Age Range
N/A to 20 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
210
Participant Inclusion 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
Participant Exclusion 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
Interventions
Procedure; surgical procedure; null; []
Design Details
Sorry, this information is not available
Study Design
Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific Title
Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
Secondary Trial Identifying Number
SIOP-95-1; EU-96053
Website
http://cancer.gov/clinicaltrials/SIOP-95-1
Study Funded By
Societe Internationale d'Oncologie Pediatrique
Funder Type
Sorry, this information is not available
Study Sponsored By
Societe Internationale d'Oncologie Pediatrique
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

01 Nov 1999

Last Updated

23 Aug 2013

Date Record Refreshed on UKCTG

24 Jul 2015