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NCT02265770

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

Datenbasis: WHO (Import vom 29.03.2024)
Geändert: 29.09.2023, 01:00
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Childhood Ependymoma

Interventions (Datenquelle: WHO)

Drug: 16 weeks of VEC + CDDP;Drug: VEC + HD-MTX;Drug: Chemotherapy + Valproate;Radiation: Conformal radiotherapy;Drug: VEC;Drug: Chemotherapy;Radiation: conformal radiotherapy +/- boost

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Gender: All
Maximum age: 22 Years
Minimum age: N/A

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

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/ct2/show/NCT02265770

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02265770
Weitere Informationen zur Studie

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

An International Clinical Program for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Ependymoma

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Datenquelle: WHO)

Phase 2/Phase 3

Primäre Endpunkte (Datenquelle: WHO)

Gross Total Resection rate;Progression-Free Survival;Number of treatment responders

Sekundäre Endpunkte (Datenquelle: WHO)

Number of participants undergoing a second-look surgery;Overall Survival;Quality of Survival;Evaluation of neuropsychological morbidity;Comparison of neuroendocrine morbidity;Number of participants with adverse events as a measure of safety and tolerability;Radiotherapy-free survival rate;Efficacy in each molecular sub-group;Concordance between central and local radiological assessment of the efficacy of post-operative chemotherapy

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Austria, Belgium, Czech Republic, Czechia, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Slovenia, Spain, Sweden, Switzerland, United Kingdom

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Pierre LEBLOND, MD
IHOP
+33 4 69 16 66 14
pierre.leblond@lyon.unicancer.fr

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Pierre LEBLOND, MD
IHOP
+33 4 69 16 66 14
pierre.leblond@lyon.unicancer.fr

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

2013-002766-39
VHP358
SIOP Ependymoma II (ET-13-002)
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