Table 1.

Eligibility and exclusion criteria for the randomised part of the SIOP-LGG 2004 trial.

Eligibility: •Age: children and adolescents up to the completion of the 16th year of life. • Histology: Low grade glioma according to ICD-O Code ○ Children with chiasmatic-hypothalamic tumours may be eligible without histological diagnosis, if neuroradiologic findings meet unequivocal criteria for the presence of a low grade glioma. •Primary tumour localisation intracranial and/or spinal cord. •Disseminated low grade glioma •Primary tumour diagnosis without pretreatment with chemotherapy or radiotherapy •Informed consent given by the patient and/or his legal guardian (parents)

Exclusion •Associated genetic conditions like neurofibromatosis NF I or tuberous sclerosis •Primary diffuse intrinsic tumours of the pons, even if histologically astrocytoma I/II •Low grade, but non-glial, rare intracranial neoplasms •Pretreatment with chemo- or radiotherapy (except for steroids) •Preexisting impairments of health status, making the conduct of the study impossible or ethically unwise. •Evidence of pregnancy or lactation period

Randomization: All eligible patients without Neurofibromatosis NF I (receiving chemotherapy as their first non-surgical therapy) were eligible for randomisation.

Participation in another clinical study: In case the patient participated in another clinical study simultaneously to being enrolled in the study SIOP-LGG 2004, which was not interfering with the present treatment strategy (e.g. endocrinologic study), this should be known to the national study chairmen.

Medication: Concomitant medication for associated or other conditions (e.g. hormone replacement, anticonvulsants), not containing cytostatic drugs, should be recorded, but was no exclusion criteria.