SIOP-EP-II
An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma
Rekrutierend
NCT-Nummer:
NCT02265770
Studienbeginn:
Juni 2015
Letztes Update:
26.04.2024
Wirkstoff:
16 weeks of VEC + CDDP, VEC + HD-MTX, Chemotherapy + Valproate, VEC, Chemotherapy
Indikation (Clinical Trials):
Ependymoma
Geschlecht:
Alle
Altersgruppe:
Alle
Phase:
-
Sponsor:
Centre Leon Berard
Collaborator:
-
Studienleiter
Pierre LEBLOND, MD Principal InvestigatorIHOP
Kontakt
Pierre LEBLOND, MD Kontakt: Phone: +33 4 69 16 66 14 E-Mail: pierre.leblond@lyon.unicancer.fr» Kontaktdaten anzeigen
Studienlocations (3 von 40)
Graz Austria Liege Belgium Brno Czechia Aarhus Denmark Strasbourg France Marseille Dijon Besançon Brest Bordeaux Toulouse Montpellier Paris Villejuif Rennes Tours La Tronche Saint-Etienne Angers Reims Vandoeuvre-les-Nancy Lille Clermont-Ferrand Lyon Rouen Amiens Poitiers Limoges Nice Saint-Denis Hamburg Germany Dublin Ireland Milan Italy Utrecht Netherlands Bergen Norway Ljubljana Slovenia Sevilla Spain Lund Sweden Zurich Switzerland Nottingham United Kingdom
University Medical Center Hamburg-Eppendorf 20246 Hamburg (Hamburg) GermanyRekrutierend » Google-Maps Ansprechpartner: Stefan Rutkowski, MD E-Mail: s.rutkowski@uke.de» Ansprechpartner anzeigen Medical University of Graz-Department of Pediatrics and Adolescent Medicine 8036 Graz AustriaRekrutierend » Google-Maps Ansprechpartner: Martin Benesch, MD Phone: +43 (0) 316/385-80427 E-Mail: martin.benesch@klinikum-graz.at» Ansprechpartner anzeigen CHR de la CITADELLE 4000 Liege BelgiumRekrutierend » Google-Maps Ansprechpartner: Caroline Piette Phone: +32 4 225 60 97 E-Mail: caroline.piette@chrcitadelle.be» Ansprechpartner anzeigen University Hospital Brno 61300 Brno CzechiaRekrutierend » Google-Maps Ansprechpartner: Jaroslav Sterba, MD Phone: +420 532 234 600/755 E-Mail: jsterb@fnbrno.cz» Ansprechpartner anzeigen Aarhus University Hospital 8200 Aarhus DenmarkRekrutierend » Google-Maps Ansprechpartner: Pernille Wendtland Edslev Phone: +45 78451701 E-Mail: pernedsl@rm.dk» Ansprechpartner anzeigen CHRU STRASBOURG - Hôpital de Hautepierre 67098 Strasbourg FranceRekrutierend » Google-Maps Ansprechpartner: Natacha Entz-Werle, MD Phone: +33 3 88 12 83 96 E-Mail: natacha.entz-werle@chru-strasbourg.fr» Ansprechpartner anzeigen AP-HM - Hôpital d'Enfants de La Timone 13385 Marseille FranceRekrutierend » Google-Maps Ansprechpartner: Nicolas André, MD, PhD Phone: +33 4 91 38 68 19 E-Mail: nicolas.andre@ap-hm.fr» Ansprechpartner anzeigen CHU Dijon - Hôpital des Enfants 21079 Dijon FranceRekrutierend » Google-Maps Ansprechpartner: Claire Briandet, MD Phone: 03 80 29 34 14 Phone (ext.): +33 E-Mail: claire.briandet@chu-dijon.fr» Ansprechpartner anzeigen CHRU BESANCON - Hôpital Jean Minjoz 25030 Besançon FranceRekrutierend » Google-Maps Ansprechpartner: Véronique Laithier, MD Phone: +33 3 81 66 81 66 E-Mail: vlaithier@chu-besançon.fr» Ansprechpartner anzeigen CHRU BREST - Hôpital Morvan 29609 Brest FranceRekrutierend » Google-Maps Ansprechpartner: Liana-Stefania Carausu, MD Phone: +33 2 98 22 33 81 E-Mail: liana.carausu@chu-brest.fr» Ansprechpartner anzeigen CHU de Bordeaux-Hôpital des enfants Pellegrin 33000 Bordeaux FranceRekrutierend » Google-Maps Ansprechpartner: Céline Icher, MD Phone: +33 5 57 82 04 34 E-Mail: celine.icher@chu-bordeaux.fr» Ansprechpartner anzeigen CHU de TOULOUSE - Hôpital des Enfants 31059 Toulouse FranceRekrutierend » Google-Maps Ansprechpartner: Anne-Isabelle Bertozzi-Salamon, MD Phone: +33 5 34 55 86 13 E-Mail: bertozzi.ai@chu-toulouse.fr» Ansprechpartner anzeigen CHRU MONTPELLIER - Hôpital Arnaud de Villeneuve 34295 Montpellier FranceRekrutierend » Google-Maps Ansprechpartner: Nicolas Sirvent, MD Phone: +33 4 67 33 65 19 E-Mail: n-sirvent@chu-montpellier.fr» Ansprechpartner anzeigen Fondation Institut Curie 75005 Paris FranceRekrutierend » Google-Maps Ansprechpartner: François Doz, MD Phone: +33 1 44 32 46 01 E-Mail: francois.doz@curie.fr» Ansprechpartner anzeigen Institut Gustave Roussy 94805 Villejuif FranceRekrutierend » Google-Maps Ansprechpartner: Léa Guérrini-Rousseau, MD Phone: +33 1 42 11 42 11 E-Mail: lea.guerrini-rousseau@gustaveroussy.fr» Ansprechpartner anzeigen CHU de RENNES - Hôpital Sud 35203 Rennes FranceRekrutierend » Google-Maps Ansprechpartner: Charline Normand, MD Phone: +33 2 99 26 58 35 E-Mail: charline.normand@chu-rennes.fr» Ansprechpartner anzeigen CHRU Tours - Hôpital Clocheville 37044 Tours FranceRekrutierend » Google-Maps Ansprechpartner: Pascale Blouin, MD Phone: 02 47 47 49 72 Phone (ext.): +33 E-Mail: p.blouin@chu-tours.fr» Ansprechpartner anzeigen CHU GRENOBLE - Hôpital Couple-Enfant 38700 La Tronche FranceRekrutierend » Google-Maps Ansprechpartner: Anne Pagnier, MD Phone: +33 4 76 76 54 69 E-Mail: apagnier@chu-grenoble.fr» Ansprechpartner anzeigen CHRU Saint-Etienne 42055 Saint-Etienne FranceRekrutierend » Google-Maps Ansprechpartner: Sandrine Thouvenin, MD Phone: 04 77 82 88 08 Phone (ext.): +33 E-Mail: sandrine.thouvenin@chu-st-etienne.fr» Ansprechpartner anzeigen Chu Angers 49100 Angers FranceRekrutierend » Google-Maps Ansprechpartner: Emilie De Carli, MD Phone: +33 2 41 35 38 63 E-Mail: EmDecarli@chu-angers.fr» Ansprechpartner anzeigen CHU REIMS - American Memorial Hospital 51092 Reims FranceRekrutierend » Google-Maps Ansprechpartner: Claire Pluchart, MD E-Mail: cpluchart@chu-reims.fr» Ansprechpartner anzeigen CHU NANCY - Brabois Hôpital d'Enfants 54511 Vandoeuvre-les-Nancy FranceRekrutierend » Google-Maps Ansprechpartner: Pascal Chastagner, MD Phone: +33 3 83 15 46 37 E-Mail: p.chastagner@chu-nancy.fr» Ansprechpartner anzeigen Centre OSCAR LAMBRET 59000 Lille FranceRekrutierend » Google-Maps Ansprechpartner: Hélène SUDOUR, MD Phone: +33 3 20 29 59 56 E-Mail: h-sudour@o-lambret.fr» Ansprechpartner anzeigen CHU Clermont- Ferrand - Hôpital Estaing 63003 Clermont-Ferrand FranceRekrutierend » Google-Maps Ansprechpartner: Catherine Paillard, MD Phone: +33 4 73 75 00 09 E-Mail: cpaillard@chu-clermontferrand.fr» Ansprechpartner anzeigen Centre LEON BERARD 69473 Lyon FranceRekrutierend » Google-Maps Ansprechpartner: Pierre LEBLOND, MD Phone: +33 4 69 16 66 14 E-Mail: pierre.leblond@lyon.unicancer.fr» Ansprechpartner anzeigen CHU Rouen - Hôpital Charles Nicolle 76031 Rouen FranceRekrutierend » Google-Maps Ansprechpartner: Pascale Schneider, MD Phone: 02 32 88 81 91 Phone (ext.): +33 E-Mail: pascale.schneider@chu-rouen.fr» Ansprechpartner anzeigen CHU AMIENS-PICARDIE - Hôpital Nord 80054 Amiens FranceRekrutierend » Google-Maps Ansprechpartner: Antoine Gourmel, MD Phone: +33 3 22 08 80 00 E-Mail: gourmel.antoine@chu-amiens.fr» Ansprechpartner anzeigen CHU POITIERS - Hôpital de la Milétrie 86021 Poitiers FranceRekrutierend » Google-Maps Ansprechpartner: Frédéric Millot, MD Phone: +33 5 49 44 30 78 E-Mail: f.millot@chu-poitiers.fr» Ansprechpartner anzeigen CHU Limoges Limoges FranceRekrutierend » Google-Maps Ansprechpartner: Christophe Piguet, MD Phone: +33 5 55 05 68 01 E-Mail: christophe.piguet@chu-limoges.fr» Ansprechpartner anzeigen CHU Nice - Hôpital de l'Archet 2 06202 Nice FranceRekrutierend » Google-Maps Ansprechpartner: Gwénaëlle DUHIL DE BENAZE, MD E-Mail: duhildebenaze.g@chu-nice.fr» Ansprechpartner anzeigen CHU La Réunion 97400 Saint-Denis FranceRekrutierend » Google-Maps Ansprechpartner: Yves REGUERRE, MD E-Mail: Yves.reguerre@chu-reunion.fr» Ansprechpartner anzeigen Our Lady's Children's Hospital Dublin IrelandRekrutierend » Google-Maps Ansprechpartner: Michael Capra, MD Phone: +353 1 409 6659 E-Mail: Michael.capra@olhsc.ie» Ansprechpartner anzeigen Fondazione IRCCS Istituto Nazionale dei Tumori 20133 Milan ItalyRekrutierend » Google-Maps Ansprechpartner: Maura Massimino, MD Phone: +39 0223902593 E-Mail: Maura.Massimino@istitutotumori.mi.it» Ansprechpartner anzeigen Princess Maxima Center for pediatric oncology Utrecht NetherlandsRekrutierend » Google-Maps Ansprechpartner: Jasper van der Lugt, MD Phone: +31 6 1855 96 94 E-Mail: J.vanderLugt@prinsesmaximacentrum.nl» Ansprechpartner anzeigen Department of Paediatric, Haukeland University Hospital 5021 Bergen NorwayRekrutierend » Google-Maps Ansprechpartner: Ingrid Kristin Torsvik, MD, PhD Phone: +47 5597 5199 E-Mail: Ingrid.kristin.torsvik@helse-bergen.no» Ansprechpartner anzeigen University Medical Center Ljubljana 1000 Ljubljana SloveniaNoch nicht rekrutierend » Google-Maps Ansprechpartner: Lidija Kitanovski, MD Phone: + 386 1 522 9215 / 522 9256 E-Mail: lidija.kitanovski@kclj.si» Ansprechpartner anzeigen Hospitales Universitarios Virgen Macarena y Virgen del Rocío Avda 41071 Sevilla SpainRekrutierend » Google-Maps Ansprechpartner: Ana Fernández-Teijeiro, MD Phone: +34677903132 E-Mail: anateijeiro@hotmail.com» Ansprechpartner anzeigen Skåne University Hospital 22185 Lund SwedenNoch nicht rekrutierend » Google-Maps Ansprechpartner: Helena Mörse, MD Phone: +46 46 178281 E-Mail: Helena.Morse@skane.se» Ansprechpartner anzeigen University Children's Hospital 8032 Zurich SwitzerlandRekrutierend » Google-Maps Ansprechpartner: Nicolas Gerber, MD Phone: +41 44 266 31 17 E-Mail: nicolas.gerber@kispi.uzh.ch» Ansprechpartner anzeigen Queen's Medical Centre Nottingham United KingdomRekrutierend » Google-Maps Ansprechpartner: Richard Grundy, MD Phone: +44 115 8230620 E-Mail: richard.grundy@nottingham.ac.uk» Ansprechpartner anzeigen Alle anzeigen
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. 1. 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. 2. 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. 3. 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.
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
Primary outcome: 1. Gross Total Resection rate (Time Frame - 3 years):Overall program, depends on the stratum (from 0.5 years to 3 years) 2. 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) 3. Number of treatment responders (Time Frame - 15 months after final patient inclusion):Objective response to chemotherapy is measured based on SIOP-E Neuro Imaging guidelines. Secondary outcome: 1. Number of participants undergoing a second-look surgery (Time Frame - 9 months) 2. 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) 3. Quality of Survival (Time Frame - from date of randomization up to 5 years after the end of treatment):Questionnaire 4. Evaluation of neuropsychological morbidity (Time Frame - from date of randomization up to 5 years after the end of treatment):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) 5. Comparison of neuroendocrine morbidity (Time Frame - from date of randomization up to 5 years after the end of treatment):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) 6. Number of participants with adverse events as a measure of safety and tolerability (Time Frame - from date of randomization up to 5 years after the end of treatment):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) 7. 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) 8. Efficacy in each molecular sub-group (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):Efficacy in each molecular subtype described in terms of Progression-Free survival and Overall Survival 9. Concordance between central and local radiological assessment of the efficacy of post-operative chemotherapy (Time Frame - 15 months after final patient inclusion):Proportion of patients in whom the result of the central radiological review confirms the local review
Experimental: Stratum 1 arm AConformal radiotherapy followed by 16 weeks of VEC + CDDP. Active Comparator: Stratum 1 arm BConformal radiotherapy. Experimental: Stratum 2 arm AVEC + HD-MTX followed by conformal radiotherapy +/- boost Active Comparator: Stratum 2 arm BVEC followed by conformal radiotherapy +/- boost Experimental: Stratum 3 arm AChemotherapy + Valproate. Active Comparator: Stratum 3 arm BChemotherapy
16 weeks of VEC + CDDP (Vincristine / Etoposide / Cyclophosphamide / Cisplatin / ):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. VEC + HD-MTX (Vincristine / Etoposide / Cyclophosphamide / Methotrexate / ):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. Chemotherapy + Valproate (Vincristine / Carboplatin / Methotrexate / Cyclophosphamide / Cisplatin / Valproate / ):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. Conformal radiotherapy:Conformal radiotherapy: 59.4Gy (children <18 months or with risk factors: 54Gy). Daily fraction 1.8 Gy, 5 fractions / week. VEC (Vincristine / Etoposide / Cyclophosphamide / ):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 Chemotherapy (Vincristine / Carboplatin / Methotrexate / Cyclophosphamide / Cisplatin / ):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. conformal radiotherapy +/- boost: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
Quelle: ClinicalTrials.gov
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