Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT00936156
Eligibility Criteria:
Inclusion Criteria:
1. 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.
2. Age at diagnosis of the medulloblastoma of more than 5 years and less than 20 years.
3. Age at diagnosis of S-PNET of more than 10 years and less than 20 years.
4. Nutritional and general status compatible with treatment, Lansky score \> 60.
5. Estimated life expectancy \> 1 months.
6. Radiographs must be available for the second reading in dicom format on a CD-ROM.
7. Hematological function at diagnosis: PMN \> 1.0 x 109/l and platelets \> 100 x 109/l.
8. 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.
9. 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.
10. No organ toxicity (Grade \> 2 according to NCI-CTC coding, version 2.0)
11. No other concomitant anti-cancer treatment.
12. No prior anti-cancer therapy.
13. No prior irradiation.
14. Written informed consent signed by both parents or legal guardians
Exclusion Criteria:
1. Failure to comply with one of the inclusion criteria.
2. Severe or life-threatening infection.
3. Uncontrolled active or symptomatic intracranial hypertension.
4. Refusal of parents or legal guardian.
5. Patients incapable of undergoing medical follow-up for geographical, social or mental reasons
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
5 Years
Study:
NCT00936156
Study Brief:
Protocol Section:
NCT00936156