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Taking people in DenmarkPhase 3

Trial comparing high-dose chemotherapy with radiotherapy in children with atypical teratoid/rhabdoid tumours

Compares high-dose chemotherapy with focal radiotherapy in children with a rare brain tumour.

Key facts

Who runs it
GPOH gGmbH
Where
Aarhus N, Copenhagen Oe, and Odense C, DenmarkSee the 3 sitesAlso in 11 other countries, 73 sites
Registry title
An international trial for children with atypical teratoid/rhabdoid tumours (ATRT)
Status
Recruiting
Phase
Phase 3
People taking part
301 people, planned
Started
20 Jul 2020
Expected to end
31 May 2031
Type of study
Interventional
Record updated
14 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children under 18 with atypical teratoid/rhabdoid tumour (ATRT). It has three parts, set by age and by how the tumour responded to the first 3 courses of chemotherapy.

Age
Under 18 years at diagnosis. Part A: expected age 12-35 months at consolidation therapy. Part B: under 12 months. Part C: 36 months or older.
Sex
All sexes can join.
Disease stage
ATRT confirmed by pathology, with loss of INI1 or SMARCB1 or SMARCA4 deficiency. Parts A and C: scans and spinal fluid tests after 3 courses of chemotherapy show stable disease or better. Part B: scans and spinal fluid tests show clear sensitivity to chemotherapy.
Earlier treatment
Must have had 3 courses of induction chemotherapy as set by the protocol. Must not have had other tumour-directed chemotherapy, radiotherapy or small molecule therapy outside the SIOPE ATRT01 trial.
Biomarker or test result
Loss of INI1, or SMARCB1 or SMARCA4 deficiency, confirmed by the local pathology lab. Liver, kidney and heart function must be within the limits in the record (for example ALT or AST at most 3.0 x ULN, EF at least 50% or FS at least 29%).

Main reasons for not taking part

  • Pregnancy or breastfeeding
  • Active HBV, HCV or HIV infection (Parts A and B)
  • Ongoing uncontrolled infection
  • Taking part in another interventional trial
  • Metastatic disease at first diagnosis, or several rhabdoid tumours at once (Part A)

The registry criteria, word for word

Show all 80 criteriaShow less

Who can take part

  • Umbrella: Age at diagnosis less than 18 years
  • Part A: MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing SD or better (central review – national or regional centre)
  • Part A: ALT or AST ≤3.0 x ULN, bilirubin ≤ 1.5 x ULN
  • Part A: Creatinine ≤ 1.5 x ULN and measured GFR within normal published defined age-related values according to national standard methods
  • Part A: EF ≥50% or FS ≥29% by echocardiography
  • Part B: Enrolled in the umbrella trial
  • Part B: Received 3 courses of induction chemotherapy according to the protocol
  • Part B: Radiotherapy not admissible (e.g. <12 months or other contraindications)
  • Part B: Not eligible for the randomized trial (Part A) (e.g. refusal of randomization)
  • Part B: Written informed consent and/or assent for inclusion according to national legislation
  • Part B: Central review of pathology confirmed ATRT
  • Umbrella: Pathology compatible with ATRT and INI1 loss or SMARCB1 or SMARCA4 deficiency confirmed by local pathology lab
  • Part B: MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing clinically significant sensitivity to chemotherapy (central review – national or regional centre)
  • Part B: ALT or AST ≤3.0 x ULN, bilirubin ≤ 1.5 x ULN
  • Part B: Creatinine ≤ 1.5 x ULN and measured GFR within normal published defined age-related values according to national standard methods
  • Part B: EF ≥50% or FS ≥29% by echocardiography
  • Part C: Enrolled in the umbrella trial
  • Part C: Received 3 courses of induction chemotherapy according to the protocol
  • Part C: Aged 36 months or above OR HDCT not possible OR Not eligible for the randomized trial (Part A)
  • Part C: Written informed consent and/or assent for inclusion according to national legislation
  • Part C: Central review of pathology confirmed ATRT
  • Part C: MRI and CSF examination after 3 courses of chemotherapy and, if applicable, later showing SD or better (central review – national or regional centre)
  • Umbrella: Written informed consent and/or assent for trial participation according to national legislation
  • Part C: ALT or AST ≤3.0 x ULN, bilirubin ≤ 1.5 x ULN
  • Part C: Creatinine ≤ 1.5 x ULN and measured GFR within normal published defined age-related values according to national standard methods
  • Part C: EF ≥50% or FS ≥29% by echocardiography
  • Umbrella: Patient agrees to use effective contraception whilst on treatment
  • Part A: Enrolled in the umbrella trial
  • Part A: Received 3 courses of induction chemotherapy according to the protocol and following induction in SD or better
  • Part A: Expected age 12-35 months at time of consolidation therapy (RT or HDCT)
  • Part A: Written informed consent and/or assent for randomization according to national legislation
  • Part A: Central review of pathology confirmed ATRT

Who cannot take part

  • Part A: Previous or concomitant tumour directed chemotherapy, RT or small molecule therapy, other than within the SIOPE ATRT01 trial
  • Part B: Any contraindication to any planned chemotherapy drug according to SmPC
  • Part C: Previous or concomitant tumour directed chemotherapy, RT or small molecule therapy, other than within the SIOPE ATRT01 trial
  • Part C: Any contraindication to any planned chemotherapy drug according to SmPC
  • Part A: Any contraindication to any planned chemotherapy drug according to SmPC
  • Umbrella: Any contraindications to any planned conventional chemotherapy drug according to SmPC
  • Umbrella: Previous or concomitant tumour directed chemotherapy (more than one course of standard treatment), RT or small molecule therapy, other than within the SIOPE ATRT01 trial
  • Umbrella: Receipt of a live attenuated vaccine 30 days or fewer prior to inclusion or planned vaccination with a live attenuated vaccine during treatment or within 3 months after the last dose administration
  • Part A: Receipt of a live attenuated vaccine 30 days or fewer prior to inclusion or planned vaccination with a live attenuated vaccine during treatment or within 3 months after the last dose administration
  • Part B: Receipt of a live attenuated vaccine 30 days or fewer prior to inclusion or planned vaccination with a live attenuated vaccine during treatment or within 3 months after the last dose administration
  • Part C: Receipt of a live attenuated vaccine 30 days or fewer prior to inclusion or planned vaccination with a live attenuated vaccine during treatment or within 3 months after the last dose administration
  • Part B: Previous or concomitant tumour directed chemotherapy, radiotherapy or small molecule therapy, other than within the SIOPE ATRT01 trial
  • Part B: At time of inclusion Diarrhoea grade 3 or worse according to the CTCAE v5.0, if uncontrolled despite optimal supportive therapy
  • Part B: Pulmonary hypertension as diagnosed by a paediatric cardiologist with indirect (echocardiography) or direct signs (pulmonary artery pressure ≥25mmHg)
  • Part A: Metastatic disease at primary diagnosis
  • Part B: Known active HBV, HCV or HIV infection
  • Part B: History of thrombosis or SOS
  • Part B: Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal)
  • Part B: Hypersensitivity to the active substance or other excipients contained in one of the investigational medical products listed in the SmPC
  • Part A: History of thrombosis or SOS
  • Part A: History or presence of clinically significant cardiac disease, including, but not limited to, any of the following, if uncontrolled despite optimal supportive care: a. Sustained ventricular tachyarrhythmia b. Any ventricular fibrillation or torsade de pointes
  • Part C: Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal)
  • Part C: Hypersensitivity to the active substance or other excipients contained in one of the investigational medical products listed in the SmPC
  • Part A: At time of inclusion bradycardia defined as persistent heart rate < 50/minute if uncontrolled despite optimal supportive therapy Screening ECG with a QTcB >450msec minute if uncontrolled despite optimal supportive therapy
  • Part A: Pulmonary hypertension as diagnosed by a paediatric cardiologist with indirect (echocardiography) or direct signs (pulmonary artery pressure ≥25mmHg)
  • Part A: Known active HBV, HCV or HIV infection
  • Part A: Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal)
  • Umbrella: Hypersensitivity to the active compounds or other excipients contained in one of the investigational medical products listed in the SmPC
  • Umbrella: Any ongoing, uncontrolled, clinically significant infection (viral, bacterial or fungal)
  • Umbrella: History or presence of non-infectious pneumonitis requiring steroids
  • Part A: History or presence of non-infectious pneumonitis requiring steroids
  • Part B: History or presence of non-infectious pneumonitis requiring steroids
  • Part C: History or presence of non-infectious pneumonitis requiring steroids
  • Part A: Hypersensitivity to the active compounds or other
  • Part B: History or presence of clinically significant cardiac disease, including, but not limited to, any of the following, if uncontrolled despite optimal supportive therapy: a. Sustained ventricular tachyarrhythmia b. Any ventricular fibrillation or torsade de pointes c. Current bradycardia defined as heart rate < 50/minute d. Screening ECG with a QTcB >450msec
  • Part B: Neutropenia (ANC <0.5 x109/L) lasting 6 weeks from the start of the previous course of chemotherapy
  • Part A: Neutropenia (ANC <0.5 x109/L) lasting 6 weeks from the start of the previous course of chemotherapy
  • Part B: Participation in another interventional therapeutic clinical trial
  • Part B: Patients on coumarin-derivative anticoagulants
  • Part C: Participation in another interventional therapeutic clinical trial
  • Part A: Participation in another interventional therapeutic clinical trial
  • Part A: Patients on coumarin-derivative anticoagulants
  • Umbrella: Participation in another interventional therapeutic clinical trial
  • Umbrella: Pregnancy or breastfeeding
  • Part A: Pregnancy or breastfeeding
  • Part B: Pregnancy or breastfeeding
  • Part C: Pregnancy or breastfeeding
  • Part A: Synchronous multifocal rhabdoid tumours

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • How old is the patient who may join a trial?
  • Is this cancer newly diagnosed, or has it come back or not responded to treatment?
  • Is the patient pregnant or breastfeeding?
  • Does the patient have an infection that is not under control, or HIV or hepatitis B or C?

Where in Denmark

Also in 11 other countries, 73 sites

  • Aarhus University HospitalAarhus N, DenmarkTaking people
  • RigshospitaletCopenhagen Oe, DenmarkTaking people
  • Odense University HospitalOdense C, DenmarkTaking people

About the trial

What the trial wants to find out

Part A: To test the non-inferiority, as evaluated by OS, of three courses of HDCT compared to focal RT plus conventional chemotherapy as consolidation therapy following conventional chemotherapy in children with ATRT aged 12 – 35 months at consolidation therapy. Part B: To assess the efficacy, as evaluated by OS, of three courses of HDCT as a consolidation measure following conventional-type chemotherapy in children with ATRT aged <12 months at the time of HDCT and not eligible for randomization within Part A of this protocol, compared to historical controls. Part C: To assess the efficacy, as evaluated by overall survival, of RT as a consolidation measure combined with conventional-type chemotherapy in children aged ≥36 months with ATRT, compared to historical controls.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
An international prospective umbrella trial for children with atypical teratoid/rhabdoid tumours (ATRT) including a randomized phase III study evaluating the non-inferiority of three courses of high-dose chemotherapy (HDCT) compared to focal radiotherapy as consolidation therapy
Plain-language title
Trial comparing high-dose chemotherapy with radiotherapy in children with atypical teratoid/rhabdoid tumoursGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2022-501456-28-00, who can take part
Record updated
14 September 2026