Status:
RECRUITING
An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma
Lead Sponsor:
Centre Leon Berard
Conditions:
Childhood Ependymoma
Eligibility:
All Genders
Up to 22 years
Phase:
PHASE2
PHASE3
Brief Summary
The overall aim of this project is to improve the outcome of patients diagnosed with ependymoma by improving and harmonising the staging and the standard of care of this patient population and to impr...
Detailed Description
The Ependymoma Program is a comprehensive program to improve the accuracy of the primary diagnosis of ependymoma and explore different therapeutic strategies in children, adolescents and young adults,...
Eligibility Criteria
Inclusion
- After Initial surgery, patients will be enrolled in one of 3 different interventional strata where they will be offered a set of therapeutic interventions based on the outcome of the intervention (no measurable residue vs residual inoperable disease), their age and/or their eligibility /suitability to receive radiotherapy.
- Patients with centrally and histologically confirmed intracranial ependymoma meeting the following criteria will be enrolled into one of interventional stratum:
- Age \< 22 years old at diagnosis
- Newly diagnosed intracranial ependymoma of WHO grade II-III confirmed by central pathological review
- Post-menarchal female not pregnant or nursing (breast feeding) and with a negative beta-HCG pregnancy test prior to commencing the trial
- Males and females of reproductive age and childbearing potential with effective contraception for the duration of their treatment and 6 months after the completion of their treatment
- No contraindication to the use if one of the study drugs proposed by the protocol
- Patients and/or their parents or legal guardians willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedure
- No co-existent unrelated disease at the time of study entry that would render the patient unable to receive chemotherapy
- No signs of infection.
- Common inclusion criteria for Strata 1 and 2:
- Age \> 12 months and \< 22 years at time of study entry
- No metastasis on spinal MRI and on CSF cytology assessments
- No previous radiotherapy
- No previous chemotherapy (except steroids)
- No medical contraindication to radiotherapy and chemotherapy
- Adequate bone marrow, liver and renal functions
- Specific inclusion criteria for Stratum 1:
- • No residual measurable ependymoma based on the central neuroradiological review (R0-1-2)
- Specific inclusion criteria for Stratum 2:
- • Residual non reoperable measurable ependymoma based on the central neuroradiological review (R3-4)
- Inclusion criteria for Stratum 3:
- Children younger than 12 months at time of entry to study or any children ineligible to receive radiotherapy due to age at diagnosis, tumour location or clinician / parent decision and according to national criteria
- Adequate bone marrow, liver and renal functions
- No previous chemotherapy and radiotherapy
- No contraindication to chemotherapy Patients that do not fulfill the inclusion criteria of one of the interventional strata will be enrolled and followed up into an observational study and descriptive analysis will be performed.
- EXCLUSION CRITERIA for all interventional strata:
- Tumour entity other than primary intracranial ependymoma
- Primary diagnosis predating the opening of SIOP Ependymoma II
- Patients with WHO grade I ependymoma including ependymoma variants: myxopapillary ependymomas and subependymomas,patients with spinal cord location of the primary tumour
- Participation within a different trial for treatment of ependymoma
- Contraindication to one of the IMP used according to the SmPCs
- Concurrent treatment with any anti-tumour agents
- Inability to tolerate chemotherapy
- Unable to tolerate intravenous hydration
- Pre-existing mucositis, peptic ulcer, inflammatory bowel disease ascites, or pleural effusion.
- Strata 1 and 2:
- Ineligible to receive radiotherapy
- Patient for whom imaging remains RX despite all effort to clarify the MRI conclusion
- Stratum 3:
- Pre-existing severe hepatic and/or renal damage
- Family history of severe epilepsy
- Presence of previously undiagnosed mitochondrial disorder detected by screening as part of trial
- Elevated blood ammonium and lactate level ≥ 1.5 x upper limit of the normal
Exclusion
Key Trial Info
Start Date :
June 2 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2031
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT02265770
Start Date
June 2 2015
End Date
August 1 2031
Last Update
April 26 2024
Active Locations (40)
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1
Medical University of Graz-Department of Pediatrics and Adolescent Medicine
Graz, Austria, 8036
2
CHR de la CITADELLE
Liège, Belgium, 4000
3
University Hospital Brno
Brno, Czechia, 61300
4
Aarhus University Hospital
Aarhus, Denmark, 8200