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 @ 3:39 PM
Ignite Modification Date:
2025-12-24 @ 3:39 PM
NCT ID:
NCT01574092
Eligibility Criteria:
Inclusion criteria:
1. Histological confirmation of neoplasia, except for intrinsic brain stem tumour and optic pathway glioma in one patient with neurofibromatosis type 1 (NF1).
2. Pertaining to one of the diagnostic groups: Cohort 1: Recently diagnosed high grade glioma. Cohort 2: Recurrent high grade glioma. Cohort 3: Intrinsic brain stem tumour. Cohort 4: High risk low grade glioma.
3. Measurable primary or metastatic tumours with at least one 10 mm diameter lesion in two MR dimensions.
4. Absence of prior treatment with cisplatin or irinotecan.
5. Aged between 6 months to 18 years.
6. Lansky/Karnofsky performance status ≥ 70% (Appendix 6.1). Neurological deficits secondary to the tumour should be stable before entering the trial.
7. Patients receiving dexamethasone should be on a stable or decreasing regimen before inclusion.
8. Life expectancy ≥ 3 months.
9. Adequate organic function, including haematological, renal and hepatic function.
10. Wash-out period of at least 3 weeks after chemotherapy and 6 weeks after nitrosoureas or radiotherapy. Recovery from all toxic effects of previous treatments.
11. Subjects of fertile age should use an effective birth control method throughout the entire study. Women of child-bearing age will be included after a negative pregnancy test result.
12. Informed consent of the parents or legal representative, and informed consent of the mature minor.
Exclusion criteria:
1. Concurrent administration of any other anti-cancer treatment.
2. Pre-existing, non-controlled diarrhoea
3. Pregnancy or lactation
4. Treatment in another clinical trial.
5. Serious concomitant disease that could compromise the completion of the trial. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT01574092
Study Brief:
Protocol Section:
NCT01574092