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An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma (SIOP-EP-II)

Primary Purpose

Childhood Ependymoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
16 weeks of VEC + CDDP
VEC + HD-MTX
Chemotherapy + Valproate
Conformal radiotherapy
VEC
Chemotherapy
conformal radiotherapy +/- boost
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Ependymoma

Eligibility Criteria

undefined - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 with an ependymoma WHO grade II and III, including ependymoma variants: papillary, clear-cell and tanycytic, RELA fusion positive 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 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

Common inclusion criteria for Strata 1 and 2:

  • Age > 12 months and < 22 years at time of study entry
  • 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 at the time of study entry that would render the patient unable to receive chemotherapy
  • No medical contraindication to radiotherapy and chemotherapy
  • No signs of infection
  • 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
  • Histologically confirmed WHO Grade II-III ependymoma by central pathological review
  • Adequate bone marrow, liver and renal functions
  • No previous chemotherapy and radiotherapy
  • No contraindication to chemotherapy
  • No co-existent unrelated disease at the time of study entry that would render the patient unable to receive chemotherapy
  • No signs of infection. 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

Sites / Locations

  • Medical University of Graz-Department of Pediatrics and Adolescent MedicineRecruiting
  • CHR de la CITADELLERecruiting
  • University Hospital BrnoRecruiting
  • Aarhus University HospitalRecruiting
  • CHRU STRASBOURG - Hôpital de HautepierreRecruiting
  • AP-HM - Hôpital d'Enfants de La TimoneRecruiting
  • CHU Dijon - Hôpital des EnfantsRecruiting
  • CHRU BESANCON - Hôpital Jean MinjozRecruiting
  • CHRU BREST - Hôpital MorvanRecruiting
  • CHU de Bordeaux-Hôpital des enfants PellegrinRecruiting
  • CHU de TOULOUSE - Hôpital des EnfantsRecruiting
  • CHRU MONTPELLIER - Hôpital Arnaud de VilleneuveRecruiting
  • Fondation Institut CurieRecruiting
  • Institut Gustave RoussyRecruiting
  • CHU de RENNES - Hôpital SudRecruiting
  • CHRU Tours - Hôpital ClochevilleRecruiting
  • CHU GRENOBLE - Hôpital Couple-EnfantRecruiting
  • CHRU Saint-EtienneRecruiting
  • Chu AngersRecruiting
  • CHU REIMS - American Memorial HospitalRecruiting
  • CHU NANCY - Brabois Hôpital d'EnfantsRecruiting
  • Centre OSCAR LAMBRETRecruiting
  • CHU Clermont- Ferrand - Hôpital EstaingRecruiting
  • Centre LEON BERARDRecruiting
  • CHU Rouen - Hôpital Charles NicolleRecruiting
  • CHU AMIENS-PICARDIE - Hôpital NordRecruiting
  • CHU POITIERS - Hôpital de la MilétrieRecruiting
  • CHU LimogesRecruiting
  • CHU Nice - Hôpital de l'Archet 2Recruiting
  • CHU La RéunionRecruiting
  • University Medical Center Hamburg-EppendorfRecruiting
  • Our Lady's Children's HospitalRecruiting
  • Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
  • Princess Maxima Center for pediatric oncologyRecruiting
  • Department of Paediatric, Haukeland University HospitalRecruiting
  • University Medical Center Ljubljana
  • Hospitales Universitarios Virgen Macarena y Virgen del Rocío AvdaRecruiting
  • Skåne University Hospital
  • University Children's HospitalRecruiting
  • Queen's Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Stratum 1 arm A

Stratum 1 arm B

Stratum 2 arm A

Stratum 2 arm B

Stratum 3 arm A

Stratum 3 arm B

Arm Description

Conformal radiotherapy followed by 16 weeks of VEC + CDDP.

Conformal radiotherapy.

VEC + HD-MTX followed by conformal radiotherapy +/- boost

VEC followed by conformal radiotherapy +/- boost

Chemotherapy + Valproate.

Chemotherapy

Outcomes

Primary Outcome Measures

Gross Total Resection rate
Overall program, depends on the stratum (from 0.5 years to 3 years)
Progression-Free Survival
Number of treatment responders
Objective response to chemotherapy is measured based on SIOP-E Neuro Imaging guidelines.

Secondary Outcome Measures

Number of participants undergoing a second-look surgery
Overall Survival
Quality of Survival
Questionnaire
Evaluation of neuropsychological morbidity
Scores: evaluation of processing speed (WPPSI-III, WISC-IV, WAIS-IV), verbal skills (WPPSI-III, WISC-IV, WAIS-IV), fluid intelligence (WPPSI-III / Ravens, WISC-IV / Ravens, WAIS-IV / Ravens), working memory (K-ABC / Children's Memory Scale, WISC-IV, WAIS-IV), visuo-spatial abilities (Beery-Buktenica Developmental Test of Visual-Motor Integration/Wide Range Assessment of Visual Motor Abilities - WRAVMA), regarding ability (as to national policy/WIAT-II) and motoric speed (Perdue Pegboard)
Comparison of neuroendocrine morbidity
Weight, height and head circumference, Tanner age, early and delayed pubertal onset, blood sample analysis (evaluation of TSH, fT4, LH and FSH, oestradiol, testosterone, insulin-like growth factor 1)
Number of participants with adverse events as a measure of safety and tolerability
Determination of short and long term safety and toxicity of frontline chemotherapy based on proportion of patients experiencing toxicity grade 3 to 4 (adverse events)
Radiotherapy-free survival rate
Efficacy in each molecular sub-group
Efficacy in each molecular subtype described in terms of Progression-Free survival and Overall Survival
Concordance between central and local radiological assessment of the efficacy of post-operative chemotherapy
Proportion of patients in whom the result of the central radiological review confirms the local review

Full Information

First Posted
September 29, 2014
Last Updated
September 13, 2023
Sponsor
Centre Leon Berard
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1. Study Identification

Unique Protocol Identification Number
NCT02265770
Brief Title
An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma
Acronym
SIOP-EP-II
Official Title
An International Clinical Program for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Ependymoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2015 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
August 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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. Patients will be stratified into different treatment subgroups according to their age, the tumour location and the outcome of the initial surgery. Each subgroup will be studied in a specific randomised study to evaluate the proposed therapeutic strategies. Stratum 1: The aim of the stratum 1 is to evaluate the clinical impact of 16-week chemotherapy regimen with VEC-CDDP following surgical resection and conformal radiotherapy in terms of progression free survival in patients who are > 12 months and < 22 years at diagnosis, with completely removed intra cranial Ependymoma. Stratum 2: This stratum is designed as a phase II trial for patients who are > 12 months and < 22 years at diagnosis, with residual disease to investigate the possible activity of HD-MTX by giving to all patients the benefit of VEC chemotherapy whilst randomising half of patients to receive additional HD-MTX. Patients will receive conformal radiotherapy (cRT). For patients who remain with a residual inoperable disease after induction chemotherapy and cRT, an 8 Gy boost of radiotherapy to the residual tumour will be delivered immediately after the end of the cRT. Stratum 3 This stratum is designed as a phase II trial to evaluate the benefit of postoperative dose intense chemotherapy administered alone or in combination with valproate in children <12 months of age or those not eligible to receive radiotherapy .
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, accordingly. This program is opened to all patients diagnosed with ependymoma below the age of 22 years. It will include a centralised review of pre and post-operative imaging to assess the completeness of the resection. It will also include a central review of pathology to confirm the histological diagnosis. The biological markers 1q and 6q gain, Tenascin C status, NELL2 and LAMA2, RELA-fusion and molecular subgroup by methylation array will be prospectively assessed for prospective evaluation of disease subgroups. Further biological evaluations will be coordinated within the linked BIOMECA study. After surgery and central review of imaging and pathology, patients will be offered the opportunity to undergo second look surgery, if possible. Patients will be enrolled in one of 3 different strata according to the outcome of the initial surgical resection (residual disease vs no residual disease), their age or eligibility / suitability to receive radiotherapy. These 3 different strata correspond to 3 therapeutic strategies according to the patient status. Stratum 1 is designed as a randomised phase III study for patients who have had a complete resection, with no measurable residual disease (as confirmed by centrally reviewed MRI) and are > 12 months and < 22 years at diagnosis. Those patients will be randomised to receive conformal radiotherapy followed by either 16 weeks of chemotherapy with VEC-CDDP, or observation. Stratum 2 is designed as a randomised phase II study for patients who have inoperable measurable residual disease and who are > 12 months and < 22 years at diagnosis. Those patients will be randomised to two different treatment schedules of chemotherapy either with VEC or VEC+ high dose methotrexate (VEC +HD-MTX). After completion of the frontline chemotherapy, patients will be assessed for response (MRI) and will receive second look surgery when feasible. For those patients who remain unresectable with residual disease despite frontline chemotherapy and for whom second line surgery is not feasible, there will be a study of the safety of a radiotherapy boost of 8 Gy that will be administered to the residual tumour immediately after the completion of the conformal radiotherapy. Patients without evidence of residual disease after the chemotherapy and/or a second look surgery are not eligible for radiotherapy boost. All patients who have not shown progression under chemotherapy will receive, as maintenance therapy, a 16 week course of VEC -CDDP following completion of radiotherapy. Stratum 3 is designed as a randomised phase II chemotherapy study in children <12 months of age or those not eligible to receive radiotherapy. These patients will be randomised to receive a dose dense chemotherapy alternating myelosuppressive and relatively non-myelosuppressive drugs at 2 weekly intervals, with or without, the addition of the histone deacetylase inhibitor, valproate. Registry: Patients that do not fulfil the inclusion criteria of one of the interventional strata will be enrolled and followed up via an observational study which will be analysed descriptively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Ependymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
536 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stratum 1 arm A
Arm Type
Experimental
Arm Description
Conformal radiotherapy followed by 16 weeks of VEC + CDDP.
Arm Title
Stratum 1 arm B
Arm Type
Active Comparator
Arm Description
Conformal radiotherapy.
Arm Title
Stratum 2 arm A
Arm Type
Experimental
Arm Description
VEC + HD-MTX followed by conformal radiotherapy +/- boost
Arm Title
Stratum 2 arm B
Arm Type
Active Comparator
Arm Description
VEC followed by conformal radiotherapy +/- boost
Arm Title
Stratum 3 arm A
Arm Type
Experimental
Arm Description
Chemotherapy + Valproate.
Arm Title
Stratum 3 arm B
Arm Type
Active Comparator
Arm Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
16 weeks of VEC + CDDP
Other Intervention Name(s)
Vincristine, Etoposide, Cyclophosphamide, Cisplatin
Intervention Description
Days 1-36-71-106: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; Days 1-3-36-38-71-73-106-108: Etoposide: 100 mg/m² infused over 60 minutes; Days 1-36-71-106: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; Days 22-57-92: Cisplatin: 80 mg/m² over 4 hours + Vincristine:1.5 mg/m² (maximal dose 2 mg) i.v.
Intervention Type
Drug
Intervention Name(s)
VEC + HD-MTX
Other Intervention Name(s)
Vincristine, Etoposide, Cyclophosphamide, Methotrexate
Intervention Description
Days 1-22-43: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; Days 1-3-22-24-43-45: Etoposide: 100 mg/m² infused over 60 minutes; Days 1-22-43: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; Days 15-36-57: Administer methotrexate at 8000 mg/m² as a 24 hour IV infusion on days 15-36-57. 10% of the dose should be given over the first hour and 90% over the remaining 23 hours. The infusion must finish at 24 hours even if it has not been completed.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy + Valproate
Other Intervention Name(s)
Vincristine, Carboplatin, Methotrexate, Cyclophosphamide, Cisplatin, Valproate
Intervention Description
Days 1-57-113-169-225-281-337: Vincristine and Carboplatin; Days 15-71-127-183-239-295-351: Vincristine and Methotrexate; Days 29-85-141-197-253-309-365: Vincristine and Cyclophosphamide; Days 43-44-99-100-154-155-211-212-267-268-323-324-379-380: Cisplatin 2-day continuous infusion. Valproate: initial dose 30 mg/kg/day for two weeks in 2 divided doses (BID 15 mg/kg). Increasing weekly up to 40 - 50 - 60 mg/kg/day in 2 divided doses.
Intervention Type
Radiation
Intervention Name(s)
Conformal radiotherapy
Intervention Description
Conformal radiotherapy: 59.4Gy (children <18 months or with risk factors: 54Gy). Daily fraction 1.8 Gy, 5 fractions / week.
Intervention Type
Drug
Intervention Name(s)
VEC
Other Intervention Name(s)
Vincristine, Etoposide, Cyclophosphamide
Intervention Description
D1: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; D1-D3: Etoposide: 100 mg/m² infused over 60 minutes; D1: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; D22: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; D22-D24: Etoposide: 100 mg/m² infused over 60 minutes; D22: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; D43: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; D43-D45: Etoposide: 100 mg/m² infused over 60 minutes; D43: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Vincristine, Carboplatin, Methotrexate, Cyclophosphamide, Cisplatin
Intervention Description
Days 1-57-113-169-225-281-337: Vincristine and Carboplatin; Days 15-71-127-183-239-295-351: Vincristine and Methotrexate; Days 29-85-141-197-253-309-365: Vincristine and Cyclophosphamide; Days 43-44-99-100-154-155-211-212-267-268-323-324-379-380: Cisplatin 2-day continuous infusion.
Intervention Type
Radiation
Intervention Name(s)
conformal radiotherapy +/- boost
Intervention Description
Conformal radiotherapy: 59.4Gy (children <18 months or with risk factors: 54Gy). Daily fraction 1.8 Gy, 5 fractions / week. In case of persistent residue : Boost of radiation 8 Gy in 2 equivalent fractions
Primary Outcome Measure Information:
Title
Gross Total Resection rate
Description
Overall program, depends on the stratum (from 0.5 years to 3 years)
Time Frame
3 years
Title
Progression-Free Survival
Time Frame
from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 4.5 years
Title
Number of treatment responders
Description
Objective response to chemotherapy is measured based on SIOP-E Neuro Imaging guidelines.
Time Frame
15 months after final patient inclusion
Secondary Outcome Measure Information:
Title
Number of participants undergoing a second-look surgery
Time Frame
9 months
Title
Overall Survival
Time Frame
from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years after the final patient inclusion
Title
Quality of Survival
Description
Questionnaire
Time Frame
from date of randomization up to 5 years after the end of treatment
Title
Evaluation of neuropsychological morbidity
Description
Scores: evaluation of processing speed (WPPSI-III, WISC-IV, WAIS-IV), verbal skills (WPPSI-III, WISC-IV, WAIS-IV), fluid intelligence (WPPSI-III / Ravens, WISC-IV / Ravens, WAIS-IV / Ravens), working memory (K-ABC / Children's Memory Scale, WISC-IV, WAIS-IV), visuo-spatial abilities (Beery-Buktenica Developmental Test of Visual-Motor Integration/Wide Range Assessment of Visual Motor Abilities - WRAVMA), regarding ability (as to national policy/WIAT-II) and motoric speed (Perdue Pegboard)
Time Frame
from date of randomization up to 5 years after the end of treatment
Title
Comparison of neuroendocrine morbidity
Description
Weight, height and head circumference, Tanner age, early and delayed pubertal onset, blood sample analysis (evaluation of TSH, fT4, LH and FSH, oestradiol, testosterone, insulin-like growth factor 1)
Time Frame
from date of randomization up to 5 years after the end of treatment
Title
Number of participants with adverse events as a measure of safety and tolerability
Description
Determination of short and long term safety and toxicity of frontline chemotherapy based on proportion of patients experiencing toxicity grade 3 to 4 (adverse events)
Time Frame
from date of randomization up to 5 years after the end of treatment
Title
Radiotherapy-free survival rate
Time Frame
from date of randomization until the date of first documented progression or date of death from any cause, or radiotherapy intervention, whichever came first, up to 2.5 years after the final patient inclusion
Title
Efficacy in each molecular sub-group
Description
Efficacy in each molecular subtype described in terms of Progression-Free survival and Overall Survival
Time Frame
from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years after the final patient inclusion
Title
Concordance between central and local radiological assessment of the efficacy of post-operative chemotherapy
Description
Proportion of patients in whom the result of the central radiological review confirms the local review
Time Frame
15 months after final patient inclusion

10. Eligibility

Sex
All
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre LEBLOND, MD
Phone
+33 4 69 16 66 14
Email
pierre.leblond@lyon.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre LEBLOND, MD
Organizational Affiliation
IHOP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz-Department of Pediatrics and Adolescent Medicine
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Benesch, MD
Phone
+43 (0) 316/385-80427
Email
martin.benesch@klinikum-graz.at
First Name & Middle Initial & Last Name & Degree
Martin Benesch, MD
Facility Name
CHR de la CITADELLE
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Piette
Phone
+32 4 225 60 97
Email
caroline.piette@chrcitadelle.be
First Name & Middle Initial & Last Name & Degree
Caroline Piette, MD
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
61300
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslav Sterba, MD
Phone
+420 532 234 600/755
Email
jsterb@fnbrno.cz
First Name & Middle Initial & Last Name & Degree
Jaroslav Sterba, MD
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pernille Wendtland Edslev
Phone
+45 78451701
Email
pernedsl@rm.dk
First Name & Middle Initial & Last Name & Degree
Pernille Wendtland Edslev, MD
Facility Name
CHRU STRASBOURG - Hôpital de Hautepierre
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natacha Entz-Werle, MD
Phone
+33 3 88 12 83 96
Email
natacha.entz-werle@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Natacha Entz-Werle, MD
Facility Name
AP-HM - Hôpital d'Enfants de La Timone
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Claude Gentet, MD
Phone
+33 4 91 38 68 21
Email
jean-claude.gentet@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Jean-Claude Gentet, MD
Facility Name
CHU Dijon - Hôpital des Enfants
City
Dijon
State/Province
Côte d'Or
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Briandet, MD
Phone
03 80 29 34 14
Ext
+33
Email
claire.briandet@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Claire Briandet, MD
Facility Name
CHRU BESANCON - Hôpital Jean Minjoz
City
Besançon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Laithier, MD
Phone
+33 3 81 66 81 66
Email
vlaithier@chu-besançon.fr
First Name & Middle Initial & Last Name & Degree
Véronique Laithier, MD
Facility Name
CHRU BREST - Hôpital Morvan
City
Brest
State/Province
Finistère
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liana-Stefania Carausu, MD
Phone
+33 2 98 22 33 81
Email
liana.carausu@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Philippe Le Moine, MD
First Name & Middle Initial & Last Name & Degree
Liana-Stefania Carausu
Facility Name
CHU de Bordeaux-Hôpital des enfants Pellegrin
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline Icher, MD
Phone
+33 5 57 82 04 34
Email
celine.icher@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Céline Icher, MD
Facility Name
CHU de TOULOUSE - Hôpital des Enfants
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Isabelle Bertozzi-Salamon, MD
Phone
+33 5 34 55 86 13
Email
bertozzi.ai@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Anne-Isabelle Bertozzi-Salamon, MD
Facility Name
CHRU MONTPELLIER - Hôpital Arnaud de Villeneuve
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Sirvent, MD
Phone
+33 4 67 33 65 19
Email
n-sirvent@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Nicolas Sirvent, MD
First Name & Middle Initial & Last Name & Degree
Gilles Palenzuela, MD
Facility Name
Fondation Institut Curie
City
Paris
State/Province
Ile-De-France
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Doz, MD
Phone
+33 1 44 32 46 01
Email
francois.doz@curie.fr
First Name & Middle Initial & Last Name & Degree
François Doz, MD
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Ile-de-France
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Léa Guérrini-Rousseau, MD
Phone
+33 1 42 11 42 11
Email
lea.guerrini-rousseau@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Léa Guérrini-Rousseau, MD
Facility Name
CHU de RENNES - Hôpital Sud
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35203
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charline Normand, MD
Phone
+33 2 99 26 58 35
Email
charline.normand@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Céline Chappe, MD
Facility Name
CHRU Tours - Hôpital Clocheville
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale Blouin, MD
Phone
02 47 47 49 72
Ext
+33
Email
p.blouin@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Pascale Blouin, MD
Facility Name
CHU GRENOBLE - Hôpital Couple-Enfant
City
La Tronche
State/Province
Isère
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Pagnier, MD
Phone
+33 4 76 76 54 69
Email
apagnier@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Anne Pagnier, MD
Facility Name
CHRU Saint-Etienne
City
Saint-Etienne
State/Province
Loire
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine Thouvenin, MD
Phone
04 77 82 88 08
Ext
+33
Email
sandrine.thouvenin@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Sandrine Thouvenin, MD
Facility Name
Chu Angers
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie De Carli, MD
Phone
+33 2 41 35 38 63
Email
EmDecarli@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Emilie De Carli, MD
Facility Name
CHU REIMS - American Memorial Hospital
City
Reims
State/Province
Marne
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Pluchart, MD
Email
cpluchart@chu-reims.fr
First Name & Middle Initial & Last Name & Degree
Claire Pluchart, MD
Facility Name
CHU NANCY - Brabois Hôpital d'Enfants
City
Vandoeuvre-les-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Chastagner, MD
Phone
+33 3 83 15 46 37
Email
p.chastagner@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Ludovic Mansuy, MD
First Name & Middle Initial & Last Name & Degree
Pascal Chastagner, MD
Facility Name
Centre OSCAR LAMBRET
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène SUDOUR, MD
Phone
+33 3 20 29 59 56
Email
h-sudour@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Hélène SUDOUR, MD
Facility Name
CHU Clermont- Ferrand - Hôpital Estaing
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Paillard, MD
Phone
+33 4 73 75 00 09
Email
cpaillard@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Justyna Kanold, MD
Facility Name
Centre LEON BERARD
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69473
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre LEBLOND, MD
Phone
+33 4 69 16 66 14
Email
pierre.leblond@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Pierre Leblond, MD
Facility Name
CHU Rouen - Hôpital Charles Nicolle
City
Rouen
State/Province
Seine Maritime
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale Schneider, MD
Phone
02 32 88 81 91
Ext
+33
Email
pascale.schneider@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Pascale Schneider, MD
Facility Name
CHU AMIENS-PICARDIE - Hôpital Nord
City
Amiens
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Devoldere, MD
Phone
+33 3 22 66 89 50
Email
devoldere.catherine@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Catherine Devoldere, MD
Facility Name
CHU POITIERS - Hôpital de la Milétrie
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Millot, MD
Phone
+33 5 49 44 30 78
Email
f.millot@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Frédéric Millot, MD
Facility Name
CHU Limoges
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Piguet, MD
Phone
+33 5 55 05 68 01
Email
christophe.piguet@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Christophe Piguet, MD
Facility Name
CHU Nice - Hôpital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine SOLER, MD
Phone
+33492039268
Email
soler.c@chu-nice.fr
Facility Name
CHU La Réunion
City
Saint-Denis
ZIP/Postal Code
97400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves REGUERRE, MD
Email
Yves.reguerre@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Yves Reguerre, MD
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Rutkowski, MD
Email
s.rutkowski@uke.de
First Name & Middle Initial & Last Name & Degree
Stefan Rutkowski, MD
Facility Name
Our Lady's Children's Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Capra, MD
Phone
+353 1 409 6659
Email
Michael.capra@olhsc.ie
First Name & Middle Initial & Last Name & Degree
Michael Capra, MD
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maura Massimino, MD
Phone
+39 0223902593
Email
Maura.Massimino@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Maura Massimino, MD
Facility Name
Princess Maxima Center for pediatric oncology
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasper van der Lugt, MD
Phone
+31 6 1855 96 94
Email
J.vanderLugt@prinsesmaximacentrum.nl
First Name & Middle Initial & Last Name & Degree
Jasper van der Lugt, MD
Facility Name
Department of Paediatric, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Kristin Torsvik, MD, PhD
Phone
+47 5597 5199
Email
Ingrid.kristin.torsvik@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Ingrid Kristin Torsvik, MD, PhD
Facility Name
University Medical Center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lidija Kitanovski, MD
Phone
+ 386 1 522 9215 / 522 9256
Email
lidija.kitanovski@kclj.si
First Name & Middle Initial & Last Name & Degree
Lidija Kitanovski, MD
Facility Name
Hospitales Universitarios Virgen Macarena y Virgen del Rocío Avda
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Fernández-Teijeiro, MD
Phone
+34677903132
Email
anateijeiro@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ana Fernández-Teijeiro, MD
Facility Name
Skåne University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Mörse, MD
Phone
+46 46 178281
Email
Helena.Morse@skane.se
First Name & Middle Initial & Last Name & Degree
Helena Mörse, MD
Facility Name
University Children's Hospital
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Gerber, MD
Phone
+41 44 266 31 17
Email
nicolas.gerber@kispi.uzh.ch
First Name & Middle Initial & Last Name & Degree
Nicolas Gerber, MD
Facility Name
Queen's Medical Centre
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Grundy, MD
Phone
+44 115 8230620
Email
richard.grundy@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Richard Grundy, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35720069
Citation
Leblond P, Massimino M, English M, Ritzmann TA, Gandola L, Calaminus G, Thomas S, Perol D, Gautier J, Grundy RG, Frappaz D. Toward Improved Diagnosis Accuracy and Treatment of Children, Adolescents, and Young Adults With Ependymoma: The International SIOP Ependymoma II Protocol. Front Neurol. 2022 Jun 2;13:887544. doi: 10.3389/fneur.2022.887544. eCollection 2022.
Results Reference
derived

Learn more about this trial

An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma

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