E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glioma supratentorial de alto grado recién diagnosticado |
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E.1.1.1 | Medical condition in easily understood language |
Los niños con tumor cerebral recién diagnosticado (glioma supratentorial de alto grado) son elegibles, siempre y cuando el tumor no se haya extendido. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10026659 |
E.1.2 | Term | Malignant oligodendroglioma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030286 |
E.1.2 | Term | Oligodendroglioma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018338 |
E.1.2 | Term | Glioma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030288 |
E.1.2 | Term | Oligodendroglioma malignant |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027744 |
E.1.2 | Term | Mixed astrocytoma-oligodendroglioma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065443 |
E.1.2 | Term | Malignant glioma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002226 |
E.1.2 | Term | Anaplastic ependymoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Determinar el benificio de la adición de bevacizumab a la radioterapia postoperatoria con temozolomida (TMZ) concomitante y adyuvante. |
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E.2.2 | Secondary objectives of the trial |
Evaluar la eficacia, seguridad y tolerabilidad de la adición de bevacizumab a la radioterapia postoperatoria con temozolomida (TMZ) concomitante y adyuvante. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Obtención del consentimiento informado por escrito del paciente, sus padres o su representante legal. - Edad en el momento de la aleatorización: 3 a < 18 años - Glioma supratentorial de alto grado localizado que no afecte al tronco encefálico , de grado III y IV de la OMS, recién diagnosticado - Diagnóstico histológico local confirmado por un anatomopatólogo de referencia designado - Capacidad de comenzar el tratamiento del estudio entre 4 semanas después de la cirugía craneal y como máximo 6 semanas después de la última intervención de cirugía mayor. - Adecuada función de la médula ósea, coagulación, función hepática y renal |
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E.4 | Principal exclusion criteria |
- GAG metastásico, definido como evidencia de diseminación neuroaxial en la RM de columna o citología de LCR positiva - Gliomatosis cerebral, definida según la OMS (GAG multifocal) - Cualquier enfermedad o proceso que contraindique el uso de la medicación o tratamiento del estudio o que supongan un riesgo inaceptable para el paciente de sufrir complicaciones relacionadas con el tratamiento. - Evidencia radiológica de hemorragia intracraneal quirúrgicamente relacionada. - Diagnóstico previo de una neoplasia maligna + período sin enfermedad menor de 5 años. - Tratamiento antineoplásico sistémico previo. - Radiación previa del cráneo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Supervivencia Libre de Episodios (SLE) - es el tiempo transcurrido desde la aleatorización hasta la fecha del primer episodio que afecta a la SLE, definido como progresión tumoral, recidiva tumoral, segunda neoplasia maligna primaria distinta del GAG o muerte por cualquier causa. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Supervivencia Global (OS) 2. Supervivencia libre de episodios (EFS) 3. Seguridad, viabilidad y tolerabilidad |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Global y a 12 meses. 2. 6, 12 y 24 meses 3. Durante todo el tiempo |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerabilidad, vigilancia de efectos tardíos |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
RAD +TMZ +/- BEV; Seguido por 12 ciclos de adyuvancia : TMZ+/- Bev |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Si el CIVD no recomienda la interrupción prematura del ensayo por inutilidad o por problemas de seguridad, se considerará como final del estudio la fecha de la visita clínica programada final del último paciente que complete el estudio o la fecha en que se reciba el último dato del último paciente que sea necesario para el análisis de la SG, lo que suceda más tarde. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |