Status:
COMPLETED
Treatment of High-Risk Cerebral Primitive Neuroectodermal Tumors in Children Aged Over 5 Years
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Metastatic, Cerebral Primitive Neuroectodermal Tumors
Eligibility:
All Genders
Up to 5 years
Phase:
PHASE2
Brief Summary
Primary objective : To increase the 3 year progression-free survival from 40% to 60%. Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged over 5 years.
Eligibility Criteria
Inclusion
- Type of tumor:
- Metastatic medulloblastoma whatever the quality of the initial resection (radiologically visible metastases by MRI and/or CSF invaded by at least one mass of tumoral cells).
- Incompletely resected local medulloblastoma with a residue \> 1.5 cm2.
- Anaplastic, large cell medulloblastoma whatever the risk criteria (localized or metastatic, complete or incomplete resection).
- Medulloblastoma with amplification of c-myc or N-myc whatever the risk criteria (local or metastatic, complete or incomplete resection).
- Local and/or metastatic sustentorial PNET.
- Age at diagnosis of the medulloblastoma of more than 5 years and less than 20 years.
- Age at diagnosis of S-PNET of more than 10 years and less than 20 years.
- Nutritional and general status compatible with treatment, Lansky score \> 60.
- Estimated life expectancy \> 1 months.
- Radiographs must be available for the second reading in dicom format on a CD-ROM.
- Hematological function at diagnosis: PMN \> 1.0 x 109/l and platelets \> 100 x 109/l.
- Hepatic function at diagnosis: serum bilirubin \< 1.5 times normal value; ASAT and ALAT \< 2.5 times normal values; prothrombin time \> 50%; fibrinogen \> 1.5 g/l.
- Renal function at diagnosis: serum creatinine according to age in a correctly hydrated child: 1 to 15 years \< 65 micromol/l; 15 to 18 years \< 110 micromol/l.
- No organ toxicity (Grade \> 2 according to NCI-CTC coding, version 2.0)
- No other concomitant anti-cancer treatment.
- No prior anti-cancer therapy.
- No prior irradiation.
- Written informed consent signed by both parents or legal guardians
Exclusion
- Failure to comply with one of the inclusion criteria.
- Severe or life-threatening infection.
- Uncontrolled active or symptomatic intracranial hypertension.
- Refusal of parents or legal guardian.
- Patients incapable of undergoing medical follow-up for geographical, social or mental reasons
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00936156
Start Date
January 1 2009
End Date
January 1 2012
Last Update
June 29 2020
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800