An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma
Status:
Recruiting
Trial end date:
2031-08-01
Target enrollment:
Participant gender:
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 .