International Consortium on Low Grade Glioma - ICLGG of the International Society of Pediatric Oncology - SIOPCooperative multicenter Study for Children and Adolescents with Low Grade Glioma SIOP - LGG 2003 - LGG2

Phase 1

• Conditions: ow grade glioma.

• Registration Number: EUCTR2005-005377-29-IE
• Lead Sponsor: Our Lady's Hospital for Sick Children

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-11
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age: children and adolescents up to age 16 years.
2. Histology: Glioma of low grade malignancy ( ICD O-Code )

Pilocytic Astrocytoma I°9241/3
Subependymal Giant Cell Astrocytoma I°9384/1
Dysembryoplastic Neuroepithelial Tumor I°9413/0
Desmoplastic Infantile Ganglioglioma I°9505/0
Ganglioglioma I° and II°9505/1
Pleomorphic Xanthoastrocytoma II°9424/3
Oligodendroglioma II°9450/3
Oligoastrocytoma II°9382/3
Astrocytoma II°9400/3
Fibrillary Astrocytoma II°9420/3
Protoplasmatic Astrocytoma II°9410/3
Gemistocytic Astrocytoma II°9411/3

Within the randomized part of the study all histologies will be randomized, since up to now there are no data to exclude any of the subgroups, e.g. children with oligodendroglioma, from this study.
Specific neuroradiological criteria may allow to diagnose a low grade chiasmatic-hypothalamic tumor without biopsy

3. Primary tumor localization: intracranial and spinal cord.
4. Dissemination: Children presenting with disseminated low grade glioma will be eligible for the study.
5. Associated conditions: Children are eligible for the trial regardless of the presence of associated genetic disease
6. Primary tumor diagnosis: The tumor should not be pretreated with chemotherapy or radiotherapy.
7. Informed consent: The patient and/or his legal guardian ( parents ) have to have declared their written informed consent to the study.

Randomization: All eligible patients without Neurofibromatosis NF I receiving chemotherapy as their first non-surgical therapy are eligible for randomization.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Primary tumor localization: diffuse intrinsic tumors of the pons, even if histologically an Astrocytoma II° is diagnosed.
Exception: pontine glioma II° in NF I patients may be entered into the study.
2. Special diagnosis: Patients presenting with rare intracranial neoplasms of low grade malignancy, but non-glial origin. Their data may be registered however, to learn about those therapeutic interventions which may prove useful to these patients and to develop separate strategies in the future. Choroid plexus papilloma should be entered on the SIOP-CPT-study.
3. Pretreatment: Children treated with chemo- or radiotherapy prior to entering the study will be evaluated separately. Previous treatment with steroids is not considered a chemotherapeutic treatment.
4. Preexisting impairments of health status, making the conduct of the study impossible or ethically unwise.
5. Evidence of pregnancy or lactation period.

In case the patient participates in another clinical study simultaneously to being enrolled in the study SIOP-LGG 2003, but not interfering with the present treatment strategy ( e.g. endocrinologic study ), this should be known to the national study chairmen.

Concommittant medication for associated or other conditions ( e.g. hormone replacement, anticonvulsants ) should be recorded, but is no exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified