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Active, not recruitingNCT02066220Updated Dec 4, 2025

International Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma

A Phase 2/3 interventional study of Radiotherapy without Carboplatin and Reduced-intensity maintenance chemotherapy in Brain Tumors, sponsored by Universitätsklinikum Hamburg-Eppendorf. Active, not recruiting at 77 sites in 16 countries. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
3 Years to 21 Years
Sex
All
01

Study summary

The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for study entry are the same for both treatment arms. With the amendment for version 12 of the protocol, patients who have a WNT-activated medulloblastoma with clinically high-risk features can be included in the PNET 5 MB WNT-HR study, and patients with a high-risk SHH medulloblastoma with TP53 mutation (both somatic or germline including mosaicism) can be included in the PNET5 MB SHH-TP53 study.

Data on patients with pathogenic germline alteration or cancer predisposition syndrome, who cannot be included in any prospective trial due to unavailability or due to physician or family decision, can be documented within the observational PNET 5 MB registry.

Read the detailed description

The aim of the LR-study is to confirm the high rate of event-free survival in patients between the ages of 3 to 5 years and less than 22, with 'standard risk' medulloblastoma with a low-risk biological profile. Patients eligible for the study will be those with non-metastatic medulloblastoma (by CSF cytology and centrally reviewed MRI imaging) at diagnosis and low-risk biological profile, defined as ß-catenin nuclear immuno-positivity by immuno-histochemistry (IHC). Patients will have undergone total or near-total tumour resection and will receive conventionally fractionated (once a day) radiotherapy with a dose of 54 Gy to the primary tumor and 18.0 Gy to the craniospinal axis. Following radiotherapy, patients will receive a reduced-intensity chemotherapy with a total of 6 cycles of chemotherapy consisting of 3 courses of cisplatin, CCNU and vincristine alternating with 3 courses of cyclophosphamide and vincristine.

The aim of the SR-study is to test whether concurrent carboplatin during radiotherapy followed by 8 cycles of maintenance chemotherapy in patients with 'standard risk' medulloblastoma with an average-risk biological profile may improve outcome. Patients eligible for the study will be those with non-metastatic medulloblastoma (by CSF cytology and centrally reviewed MRI imaging) at diagnosis and average-risk biological profile, defined as ß-catenin nuclear immuno-negativity by IHC. Patients will have undergone total or near-total tumour resection and will receive conventionally fractionated (once a day) radiotherapy with a dose of 54 Gy to the primary tumor and 23.4 Gy to the craniospinal axis. Following radiotherapy, patients will receive a modified-intensity chemotherapy with a total of 8 cycles of chemotherapy consisting of 4 courses of cisplatin, CCNU and vincristine alternating with 4 courses of cyclophosphamide and vincristine.

The primary aim of the WNT-HR study is to maintain a 3-year EFS over 80 %. The small number of patients does not allow neither conventional methods of test size and power, nor strict stopping rules. The 3-year EFS will be estimated by the Kaplan-Meier method at the end of the trial and its two-sided 95 % confidence interval will be calculated.

The primary endpoint of the SHH-TP53 study is event-free survival (EFS). The aim of the study is the comparison of EFS between patients receiving a dose reduced induction chemotherapy, radiotherapy and maintenance chemotherapy and a historic population from unpublished data.

02

Conditions studied

  • Brain Tumors

Keywords

  • pediatric brain tumor
  • medulloblastoma
  • event-free survival (EFS)
  • progression-free survival (PFS)
  • overall survival (OS)
  • PNET
  • posterior fossa
  • chemotherapy
  • radiotherapy
  • biological profile
  • ß-catenin
03

In context

Brain Neoplasms

2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.

This study's planned enrollment of 360 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.

Browse Universitätsklinikum Hamburg-Eppendorf studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age at diagnosis, at least 3 - 5 years (depending on the country) and less than 22 years (LR-arm: less than 16 years). The date of diagnosis is the date on which surgery is undertaken.
  2. proven medulloblastoma, including the following subtypes, as defined in the WHO classification (2007): classic medulloblastoma, desmoplastic/nodular medulloblastoma. Pre-treatment central pathology review is considered mandatory.

  3. Standard-risk medulloblastoma, defined as;

    • total or near total surgical resection with less than or equal to 1.5 cm2 (measured on axial plane) of residual tumour on early post-operative MRI, without and with contrast, on central review;
    • no central nervous system (CNS) on MRI (cranial and spinal) on central review;
    • no tumour cells on the cytospin of lumbar CSF
    • no clinical evidence of extra-; Patients with a reduction of postoperative residual tumor through second surgery to less than or equal to 1.5 cm2 are eligible, if if timeline for start of radiotherapy can be kept.
  4. Submission of high quality biological material including fresh frozen tumor samples for the molecular assessment of biological markers (such as the assessment of myelocytomatosis oncogene (MYC) copy number status) in national biological reference centers. Submission of blood is mandatory for all patients, who agree on germline DNA studies. Submission of CSF is recommended.
  5. No amplification of MYC or MYCN (determined by FISH).

  6. For LR-arm: Low-risk biological profile, defined as WNT subgroup positivity. The WNT subgroup is defined by the presence of (i) ß-catenin mutation (mandatory testing), or (ii) ß-catenin nuclear immuno-positivity by IHC (mandatory testing) and ß-catenin mutation, or (iii) ß-catenin nuclear immuno-positivity by IHC and monosomy 6 (optional testing).

    For SR-arm: average-risk biological profile, defined as ß-catenin nuclear immuno-negativity by IHC (mandatory) and mutation analysis (optional).

  7. No prior therapy for medulloblastoma other than surgery.
  8. Radiotherapy aiming to start no more than 28 days after surgery. Foreseeable inability to start radiotherapy within 40 days after surgery renders patients ineligible for the study.
  9. Screening for the compliance with eligibility criteria should be completed, and patient should be included into the study within 28 days after first surgery (in case of second surgery within 35 days after first surgery). Inclusion of patients is not possible later than 40 days after first tumour surgery, or after start of radiotherapy.
  10. Common toxicity criteria (CTC) grades \< 2 for liver, renal, haematological function
  11. no significant sensorineural hearing deficit as defined by pure tone audiometry with bone conduction or air conduction and normal tympanogram showing no impairment ≥ 20 decibel (dB) at 1-3 kilohertz (kHz). If performance of pure tone audiometry is not possible postoperatively, normal otoacoustic emissions are acceptable, if there is no history for hearing deficit.
  12. No medical to radiotherapy or chemotherapy, such as preexisting DNA breakage syndromes (e.g. Fanconi Anemia, Nijmegen breakage syndrome), Gorlin Syndrome or other reasons as defined by patient's clinician.
  13. No identified Turcot and Li Fraumeni syndrome.
  14. Written (and patient assent where appropriate) for therapy according to the laws of each participating country. Information must be provided to the patient on biological studies (tumour and germline), and written informed consent obtained of agreement for participation.
  15. National and local ethical committee approval according to the laws of each participating country (to include approval for biological studies).

Exclusion criteria

Exclusion Criteria:

  1. One of the inclusion criteria is lacking.
  2. Brainstem or supratentorial primitive neuro-ectodermal tumour.
  3. Atypical teratoid rhabdoid tumour.
  4. Medulloepithelioma; Ependymoblastoma
  5. Large-cell medulloblastoma, anaplastic medulloblastoma, or medulloblastoma with extensive nodularity (MBEN), centrally confirmed.
  6. Unfavourable or undeterminable biological profile, defined as amplification of MYC or MYCN, or MYC or MYCN or WNT subgroup status not determinable.
  7. medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF).
  8. Patient previously treated for a brain tumour or any type of malignant disease.
  9. DNA breakage syndromes (e.g. Fanconi anemia, Nijmegen breakage syndrome) or other, or identified Gorlin,Turcot, or Li Fraumeni syndrome.
  10. Patients who are pregnant.
  11. Female patients who are sexually active and not taking reliable .
  12. Patients who cannot be regularly followed up due to psychological, social, familial or geographic reasons.
  13. Patients in whom non-compliance with toxicity management guidelines can be expected.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    PNET 5 MB-LR (low-risk)

    Radiotherapy and reduced-intensity maintenance chemotherapy. Total treatment duration is 39 weeks.

    Radiation: Radiotherapy without Carboplatin · Drug: Reduced-intensity maintenance chemotherapy

  • Experimental
    PNET 5 MB-SR (standard-risk)

    Radiotherapy with carboplatin or radiotherapy without carboplatin and maintenance chemotherapy. Total treatment duration is 48 weeks.

    Radiation: Radiotherapy without Carboplatin · Radiation: Radiotherapy with Carboplatin · Drug: Maintenance chemotherapy

  • Experimental
    PNET 5 MB WNT-HR

    Radiotherapy adapted to age and metastatic Status and maintenance chemotherapy adapted to age. Total treatment duration is 39 to 48 weeks.

    Drug: Maintenance chemotherapy · Radiation: WNT-HR < 16 years · Radiation: WNT-HR >= 16 years

  • Experimental
    PNET 5 MB SHH-TP53

    Reduced chemotherapy with Doxorubicin, VCR, HD-MTX, Carboplatin, and MTX intraventricularly Stratification of radiotherapy according to * presence of metastasis * germline mutation in TP53 (including mosaicism) Maintenance chemotherapy with VBL Total treatment duration is 1 year

    Drug: Induction Chemotherapy · Radiation: SHH-TP53 M0 · Radiation: SHH-TP53 M+ (germline) · Radiation: SHH-TP53 (somatic) · Drug: Vinblastin Maintenance

Interventions

  • RadiationRadiotherapy without Carboplatin

    Brain - 23.40 Gy in 13 daily fractions of 1.80 Gy Spine - 23.40 Gy in 13 daily fractions of 1.80 Gy Primary tumour boost - 30.60 Gy in 17 daily fractions of 1.80 Gy Total dose - 54 Gy Duration of radiotherapy 6 weeks LR Arm after Amendment (Protocol version 11- 17 Nov 2014): Brain - 18.0 Gy in 10 daily fractions of 1.80 Gy Spine - 18.0 Gy in 10 daily fractions of 1.80 Gy Primary tumour boost - 36.0 Gy in 20 daily fractions of 1.80 Gy Total dose - 54 Gy Duration of radiotherapy 6 weeks

  • DrugReduced-intensity maintenance chemotherapy

    Starts 6 weeks after radiotherapy. 6 cycles alternating Regimen A and Regimen B. Regimen A (cycles 1, 3, 5): cisplatin 70 mg/m2 day 1, CCNU 75 mg/m2 day 1, vincristine 1.5 mg/m2 days 1, 8 and 15, Regimen B: (cycles 2, 4, 6): cyclophosphamide 1 x 1000 mg/m2 days 1-2, vincristine 1.5 mg/m2 day 1. Interval after cycle A: 6 weeks, after cycle B: 3 weeks, for a total duration of 27 weeks. Cumulative doses of chemotherapy drugs: cisplatin 210 mg/m2, lomustine (CCNU) 225 mg/m2, vincristine 18 mg/m2, cyclophosphamide 6 g/m2.

    Also known as: Cisplatin, Lomustin (CCNU), Vincristine, Cyclophosphamide

  • RadiationRadiotherapy with Carboplatin

    Brain - 23.40 Gy in 13 daily fractions of 1.80 Gy Spine - 23.40 Gy in 13 daily fractions of 1.80 Gy Primary tumour boost - 30.60 Gy in 17 daily fractions of 1.80 Gy Total dose - 54 G Carboplatin 35 mg/m2 5 times/week.

    Also known as: Carboplatin

  • DrugMaintenance chemotherapy

    Starts 6 weeks after radiotherapy. 8 cycles alternating Regimen A and Regimen B. Regimen A (cycles 1, 3, 5, 7): cisplatin 70 mg/m2 day 1, CCNU 75 mg/m2 day 1, vincristine 1.5 mg/m2 days 1, 8 and 15 Regimen B: (cycles 2, 4, 6, 8): cyclophosphamide 1 x 1000 mg/m2 days 1-2, vincristine 1.5 mg/m2 day 1. Interval after cycle A: 6 weeks, after cycle B: 3 weeks. Duration 36 weeks. Cumulative doses of chemotherapy drugs: cisplatin 280 mg/m2, lomustine (CCNU) 300 mg/m2, vincristine 24 mg/m2, cyclophosphamide 8 g/m2, carboplatin 1050 mg/m2 (in randomized patients).

    Also known as: Cisplatin, Lomustine (CCNU), Vincristine, Cyclophosphamide

  • RadiationWNT-HR < 16 years

    Brain - 23.4 Gy in 13 daily fractions of 1.8 Gy Spine - 23.4 Gy in 13 daily fractions of 1.8 Gy Primary tumour boost - 30.6 Gy in 17 daily fractions of 1.8 Gy Boost to macroscopic metastases - 21.6 Gy in 12 daily fractions of 1.8 Gy Total dose to primary tumour - 54.0 Gy in 30 daily fractions of 1.8 Gy Total dose to cranial metastases - 45.0 Gy in 25 daily fractions of 1.8 Gy Total dose to spinal metastases - 45.0 Gy in 25 daily fractions of 1.8 Gy

  • RadiationWNT-HR >= 16 years

    Brain - 36.0 Gy in 20 daily fractions of 1.8 Gy Spine - 36.0 Gy in 20 daily fractions of 1.8 Gy Primary tumour boost - 18.0 Gy in 10 daily fractions of 1.8 Gy Metastases boost (cranial) - 14.4 Gy in 8 daily fractions of 1.8 Gy Metastases boost (spinal) - 9.0 Gy in 5 daily fractions of 1.8 Gy Total dose to primary tumour - 54.0 Gy in 30 daily fractions of 1.8 Gy Total dose to cranial metastases - 50.4 Gy in 30 daily fractions of 1.8 Gy Total dose to spinal metastases - 45.0 Gy in 25 daily fractions of 1.8 Gy

  • DrugInduction Chemotherapy

    Doxorubicin 37,5mg/m² in 24h-infusion, days 1 and 2 (If administration of doxorubicin is not deemed appropriate, doxorubicin can be substituted by carboplatin 200mg/m²) VCR 1,5mg/m² (max. dose 2mg) in short infusion, days 1, 15, 29, 43 HD-MTX 5g/m²in two doses (0.5g/m² in 0.5h and 4.5g/m² in 23.5h), days 15 and 29 (+ Leucovorin) Carboplatin 200mg/m² in 1h-infusion, days 43, 44, and 45 MTX 2mg intraventricularly, days 1-4, 15, 16, 29, 30, 43-46

  • RadiationSHH-TP53 M0

    * with VCR 1,5 mg/m2 (max. 2mg), once weekly during radiotherapy, for a maximum of 6 weeks * clinical target volume (CTV): safety margin along typical spread 10 mm: 23.4.Gy in 13 fractions to CTV. * focal RT boost to tumour bed and residual tumour (GTV) (boost: 30.6 Gy in 17 daily fractions of 1.8 Gy)

  • RadiationSHH-TP53 M+ (germline)

    craniospinal radiotherapy with boost to tumour bed, residual tumour and metastatic deposits with VCR 1,5 mg/m2 (max. 2mg), once weekly during radiotherapy, for a maximum of 6 weeks Brain - 23.4 Gy in 13 daily fractions of 1.8 Gy Spine - 23.4 Gy in 13 daily fractions of 1.8 Gy Primary tumour boost - 30.6 Gy in 17 daily fractions of 1.8 Gy Metastases boost (cranial) - 30.6 Gy in 17 daily fractions of 1.8 Gy Metastases boost (spinal) - 21.6 Gy in 12 daily fractions of 1.8 Gy Total dose to primary tumour - 54.0 Gy in 30 daily fractions of 1.8 Gy Total dose to cranial metastases - 54.0 Gy in 30 daily fractions of 1.8 Gy Total dose to spinal metastases - 45.0 Gy in 25 daily fractions of 1.8 Gy

  • RadiationSHH-TP53 (somatic)

    craniospinal radiotherapy with boost to tumour bed, residual tumour and metastatic deposits with VCR 1,5 mg/m2 (max. 2mg), once weekly during radiotherapy, for a maximum of 6 weeks Brain - 36.0 Gy in 20 daily fractions of 1.8 Gy Spine - 36.0 Gy in 20 daily fractions of 1.8 Gy Primary tumour boost - 18.0 Gy in 10 daily fractions of 1.8 Gy Metastases boost (cranial) - 18.0 Gy in 10 daily fractions of 1.8 Gy Metastases boost (spinal) - 9.0 Gy in 5 daily fractions of 1.8 Gy Total dose to primary tumour - 54.0 Gy in 30 daily fractions of 1.8 Gy Total dose to cranial metastases - 54.0 Gy in 30 daily fractions of 1.8 Gy Total dose to spinal metastases - 45 Gy in 25 daily fractions of 1.80 Gy

  • DrugVinblastin Maintenance

    Weekly VBL (5mg/m², max. 10mg/dose) for 24 weeks

06

What researchers measure

Primary outcomes

  1. 3-year Event-Free Survival (EFS)

    Time frame: LR-arm after 9 years, SR-arm after 105 events (approx. 10 years)

Secondary outcomes

  1. Overall survival

    Time frame: 10 years

  2. Pattern of relapse

    Defined in 5 categorical variables: no relapse, local relapse, distant relapse, local and distant relapse, death

    Time frame: 10 years

  3. Late effects of therapy on endocrine function

    measured as 1. subfertility (FSH \> 15 IU/L) 2. endocrine deficits (hormone supplementation necessary) 3. growth retardation (calculated as the difference in height standard deviation score from diagnose) 2 and 5 years after diagnosis and age of 18 years

    Time frame: 10 years

  4. Late effects of therapy on audiology

    measured on audiogram performed 2 years after diagnosis, grading according to Chang ototoxicity grading (Chang and Chinosornvatana 2010)

    Time frame: 8 years

  5. Late effects of therapy on neurology

    Measured as 1. presence, duration, and therapy of hydrocephalus symptoms (pre- and post-operatively) 2. presence of posterior fossa syndrome (cerebellar mutism survey after surgery, before radiotherapy) 3. cerebellar symptoms (brief ataxia rating scales 2 and 5 years after diagnosis and age of 18 years) 4. presence of symptoms for brain nerve dysfunction (2 and 5 years after diagnosis and age of 18 years)

    Time frame: 10 years

  6. Late effects of therapy on quality of survival

    measured with standardized questionnaires/ scores: 1. HUI3 (health status) 2. BRIEF (executive functions) 3. SDQ (behavioural outcome) 4. PedsQL (quality of life) 5. QLQ-C30 (quality of life) 6. MEES (neurological function, educational provision) 7. MFI (fatigue) 2 and 5 years after diagnosis and age of 18 years

    Time frame: 10 years

  7. Progression-free survival

    Time frame: 10 years

  8. Feasibility of carboplatin treatment

    measured as timely delivery of chemotherapy number of interruptions days during radiotherapy toxicities within 8 weeks after end of radiotherapy

    Time frame: approx. 7 years

  9. Residual tumor

    measured by central MRI review postoperatively

    Time frame: 6 years

  10. Leukoencephalopathy grading

    measured 2 years after diagnosis grades 0, 1, 2, 3, 4

    Time frame: 8 years

07

Study locations

77 sites
08

References and documents

Publications

  • Mikkelsen MK, Pinto SN, Chiang J, Shimony N, Gajjar A. Evolving Biology and Therapy of WNT-Activated Medulloblastoma. J Natl Compr Canc Netw. 2025 Sep 18;23(10):e257061. doi: 10.6004/jnccn.2025.7061. PubMed 40967259 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Dec 2026 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2014
First posted
Feb 19, 2014
Start
Jun 2014
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Dec 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02066220
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Deutsche Kinderkrebsstiftung
Responsible party
Sponsor
First posted
Feb 19, 2014
Start date
Jun 2014
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 4, 2025

Study contacts

Francois Doz, Prof. Dr.
principal investigator · Institut Curie Paris, France
Till Milde, Dr. med.
principal investigator · Hopp Children´s Tumor Center at the NCT (KiTZ) and German Cancer Research Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Cisplatin · Vinblastine

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