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New treatment option for Childhood Ependymoma
Official title An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma
ClinicalTrials.gov ID: NCT02265770
What this study is testing
What is 16 weeks of VEC + CDDP?
16 weeks of VEC + CDDP is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for childhood ependymoma.
Also referred to as Vincristine, Etoposide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 improve the investigators understanding of the underlying biology thereby informing future treatment. The program will evaluate new strategies for diagnosis (centralized reviews of pathology and imaging) and new therapeutic strategies in order to develop treatment recommendations.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 22
You may be able to join if
- After Initial surgery, patients will be enrolled in one of 3 different treatment strata where they will be offered a set of therapeutic interventions...
- 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...
You likely can't join if
- for all treatment 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...
- Participation within a different trial for treatment of ependymoma
- Contraindication to one of the IMP used according to the SmPCs
See the full eligibility criteria
- After Initial surgery, patients will be enrolled in one of 3 different treatment strata where they will be offered a set of therapeutic interventions based on the outcome of the intervention (no measurable residue vs...
- 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 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 for Stratum 1:
- No residual measurable ependymoma based on the central neuroradiological review (R0-1-2) Specific for Stratum 2:
- Residual non reoperable measurable ependymoma based on the central neuroradiological review (R3-4) 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 of one of the treatment strata will be enrolled and followed up into an observational study and descriptive analysis will be performed.
- for all treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Liège, Belgium
- Brno, Czechia
- Aarhus, Denmark
- Strasbourg, Bas-Rhin, France
- Marseille, Bouches-du-Rhône, France
- Dijon, Côte d'Or, France
- Besançon, Doubs, France
- Brest, Finistère, France
- Bordeaux, Gironde, France
- Toulouse, Haute-Garonne, France
- Montpellier, Herault, France
- Rennes, Ille-et-Vilaine, France
- Tours, Indre-et-Loire, France
- La Tronche, Isère, France
- Angers, Maine-et-Loire, France
- Reims, Marne, France
- Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
- Lille, Nord, France
- Saint-Étienne-de-Montluc, Pays de la Loire Region, France
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Liège, Belgium; Brno, Czechia; Aarhus, Denmark; Strasbourg, Bas-Rhin, France; Marseille, Bouches-du-Rhône, France and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.