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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00003122 |
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Date of registration:
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01/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Surgery in Treating Patients With Neuroblastoma
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Scientific title:
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Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma |
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Date of first enrolment:
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December 1994 |
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Target sample size:
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210 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00003122 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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France
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Ireland
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Italy
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Netherlands
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Spain
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Switzerland
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United Kingdom
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Contacts
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Name:
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Jean Marie Michon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Curie |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
20 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neuroblastoma
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Intervention(s)
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Procedure: surgical procedure
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Primary Outcome(s)
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Predictive factors of relapse and survival
[Time Frame: No]
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Safety and efficacy
[Time Frame: Yes]
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Secondary ID(s)
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SIOP-95-1
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CDR0000065880
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EU-96053
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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