SIOP Ependymoma II - An International Clinical Program for the diagnosis and treatment of children, adolescents and young adults affetti da Ependymoma
- Conditions
- ewly diagnosed with an intracranial or spinal ependymoma (all WHO grades) including ependymoma variants: cellular, papillary, myxopapillary, clear-cell and tanycytic) or anaplastic ependymoma.MedDRA version: 16.1Level: PTClassification code 10014967Term: EpendymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002766-39-IT
- Lead Sponsor
- CENTRE LEON BERARD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 480
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 (histology confirmed by National Reference centre for Biology and Pathology review) meeting the following criteria will be enrolled into one of interventional strata:
•Main residence in one of the participating countries,
•Age below 22 years old at the diagnosis,
•Newly diagnosed with an ependymoma WHO grade II and III, including ependymoma variants: cellular, papillary, clear-cell and tanycytic or anaplastic ependymoma.
•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 (see section 4.1.2.4 Definition of highly effective methods of contraception) for the duration of their treatment and 6 month after the completion of their treatment,
•Patients and/or their parents or legal guardians willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedure
Specific inclusion criteria have been defined for each stratum of the program.
Stratum 1:
•Age > 12 months and < 22 years at time of study entry
•No residual measurable ependymoma based on the central neuroradiological review (detailed in protocol)
•Histologically confirmed WHO Grade II-III ependymoma by central pathological review
•No metastasis on spinal MRI and on CSF cytology assessments
•No previous radiotherapy
•No previous chemotherapy (except steroids)
•No co-existent unrelated disease (e.g. renal, hematological) at the time of study entry
•No medical contraindication to radiotherapy and chemotherapy,
•No signs of infection
•Adequate bone marrow function(detailed in protocol)
•Adequate liver function (detailed in protocol)
•Adequate renal function (In case of suspected compromised renal function, glomerular filtration should be measured by an isotope GFR method such as EDTA clearance or by creatinine clearance:detailed in protocol)
Stratum 2:
•Age > 1 year and <22 years at time of entry to study
•Residual non reoperable measurable ependymoma based on central neuro-radiological review (detailed in protocol)
•Histologically confirmed WHO Grade II-III ependymoma by central pathological review
•No metastasis on spinal MRI and on CSF cytology assessments
•No previous radiotherapy
•No previous chemotherapy (except steroids)
•No co-existent unrelated disease (e.g. renal, hematological) at the time of study entry
•No medical contraindication to radiotherapy and chemotherapy,
•No signs of infection
•Adequate bone marrow function (detailed in protocol)
•Adequate liver function (In case of suspected compromised renal function, glomerular filtration should be measured by an isotope GFR method such as EDTA clearance or by creatinine clearance:detailed in protocol)
Stratum 3
•Children younger than 12 months at time of entry to study or any children ineligible to receive radiotherapy according to national criteria
•Histologically confirmed WHO Grade II-III ependymoma by central pathological review
•Adequate bone marrow func
All interventional stata
•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
•Age = 22 years
•Contraindication to one of the IMP used in this stratum according to the SmPCs in appendix 4 of this protocol” (SmPCs in appendixes are those from UK which were chosen for the assessment of the safety aspects of the study
•Concurrent treatment with any anti-tumour agents
•Inability to tolerate chemotherapy
•Unable to tolerate intravenous hydration
•Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results in the judgment of the Investigator
•Pre-existing mucositis, peptic ulcer, inflammatory bowel disease, ascites, or pleural effusion
•Pregnancy and breast feeding
Stratum 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 (liver) and/or renal (kidney) damage
Family history of severe epilepsy
•Presence of previously undiagnosed mitochondrial disorder detected by screening as part of trial
•Elevated blood ammonium level = 1.5 x upper limit of the normal
•Elevated Blood lactate level = 1.5 x upper limit of the normal
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method