| DEC-NET Serial number FR377 |
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| Published online | 25/03/2005 11.32.00 |
| Last updated | 01/09/2005 15.04.18 |
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| Other protocol ID number | SIOP-NB 2009 |
| Current trial status | Open (actively recruiting new participants) |
Major Disease
(ICD9 class) | MALIGNANT NEOPLASM OF ADRENAL GLAND |
| Experimental drug |
vincristine
Treatment regimen (dosage and duration)
1.5-2mg/m2/day by IV bolus at days 1 and 5 |
Etoposide (VP16)
Treatment regimen (dosage and duration)
150 mg/m2/day IV infusion over 2 hours at day 1 and day 3 |
Carboplatine
Treatment regimen (dosage and duration)
200 mg/m2/day as IV infusion over 1 hour at days 1 and 3 |
cyclophosphamide
Treatment regimen (dosage and duration)
300 mg/m2/day as IV infusion over 1 hour at days 1 and 5 or orally at days 2 and 3.
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Doxorubicine
Treatment regimen (dosage and duration)
30 mg/m2/day as IV infusion over 6 hours at days 4 and 5 |
| Gender | Both |
| Age (range) | > 12 months et < 20 years |
Eligibility criteria |
| Inclusion criteria |
| - Patients with unresectable INSS Stage 2 and 3 neuroblastoma.
- Non MYCN amplified tumours (established by national reference lab).
- No previous chemotherapy or radiotherapy.
- Informed parental consent.
- Registration within four weeks of biopsy (to National Data Centre).
- Meeting all eligibility criteria.
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| Exclusion criteria |
| - Staging investigations not completed according to the protocol.
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Trial design/methodology |
| Phase | 3 |
| Kind of study | Efficacy
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| Design | |
| Purpose of study |
| 1/Major:
-To determine the outcome, in particular the local control, event-free survival (80%) and overall survival, of children over the age of one year with Stage 2 and Stage 3 unresectable neuroblastoma without MYCN amplification. 2/Secondary :
- To treat all children referred to members of the European cooperative groups in a uniform manner and collect the data centrally.
-To collect and evaluate validated biological data on all cases in order to validate new prognostic markers.
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| Summary of study design, objectives, and ongoing research findings |
| The aim is to determine the outcome, in particular the local control, event-free survival and overall survival, of children over the age of one year with Stage 2 and Stage 3 unresectable neuroblastoma without MYCN amplification. The children initially receive 4 courses of chemotherapy, before surgery with possible additional chemotherapy.
The protocol consists of 2 courses of chemotherapy including carboplatine-VP16 followed 3 weeks later by a cure of CADO (Oncovin, Endoxan and Adriamycine).
The aim is to obtain a 3 year event free survival rate of 80% and a 3 year overall survival rate of 85%. |
