E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glioblastoma |
Glioblastoma |
|
E.1.1.1 | Medical condition in easily understood language |
Glioblastoma |
Glioblastoma |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
To study the safety (primary) and efficacy (secondary) of neoadjuvant radiotherapy in the surgical resection of glioblastoma (GBM). We want to verify that there are no undesirable adverse effects using this protocol compared to the Stupp regimen. |
Estudiar la seguridad (principal) y la eficacia (secundario) de la radioterapia neoadyuvante en la resección quirúrgica del glioblastoma (GBM). Deseamos verificar que no existen efectos adversos no deseados utilizando este protocolo en comparación con el régimen de Stupp. |
|
E.2.2 | Secondary objectives of the trial |
To measure progression-free survival (PFS), overall survival (OS), neurological function (NIHSS scale), cognitive function (MoCA scale, Montreal Cognitive Assessment) and quality of life determined by the EuroQol 5D, EORTC QLQ-HN35 scales (Questionnaire Quality of Life in tumors, head and neck subscale), FACT-Br (Functional Assessment of Cancer Treatment, brain subscale) and TWiST Scale (“time without symptoms or toxicity”). |
Medir la supervivencia libre de progresión (SLP), supervivencia global (SG), función neurológica (escala NIHSS), función cognitiva (Escala MoCA, Montreal Cognitive Assessment) y calidad de vida determinadas por las escalas EuroQol 5D, EORTC QLQ-HN35 (Cuestionario Calidad de Vida en tumores, subescala de cabeza y cuello), FACT-Br (Evaluación funcional del tratamiento del cáncer, subescala cerebral) y Escala TWiST (“tiempo sin síntomas ni toxicidad”). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Age between 18 and 75 years. · Unifocal disease. · Unilobar tumor. · Radiological diagnosis of unicentric supratentorial high-grade glioma, candidate for macroscopically complete resection. · Histological diagnosis of glioblastoma multiforme. |
· Edad entre 18 y 75 años. · Enfermedad unifocal. · Tumor unilobar. · Diagnóstico radiológico de glioma de alto grado supratentorial unicéntrico, candidato a resección macroscópicamente completa. · Diagnóstico histológico de glioblastoma multiforme. |
|
E.4 | Principal exclusion criteria |
· Multilobar tumor, interhemispheric or infratentorial extension, or multifocal disease. · Midline deviation greater than 1 cm. · Clinic of intracranial hypertension that requires corticosteroid treatment. · Synchronous neoplasm. · Any contraindication to surgery, radiotherapy or treatment with TMZ. · Cognitive impairment. · Refusal of informed consent. · Impossibility for 2-year follow-up. |
· Tumor multilobar, extensión interhemisférica o infratentorial, o enfermedad multifocal · Desviación de línea media superior a 1 cm. · Clínica de hipertensión intracraneal que requiera tratamiento corticoideo. · Neoplasia sincrónica. · Cualquier contraindicación para la cirugía, radioterapia o tratamiento con TMZ. · Deterioro cognitivo. · Rechazo del consentimiento informado. · Imposibilidad para el seguimiento de 2 años. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Patients may be withdrawn from the study for any of the following reasons: 1.- The patient decides not to continue in the study and/or follow-up visits; 2.- The patient does not cooperate or fails to comply with the protocol or the monitoring criteria. 3.- The patient receives some additional treatment for his neurological condition not foreseen in the protocol. 4.- Early death or other serious adverse event listed in point 9 of this protocol (It will be communicated immediately according to the usual procedure). 5.- Any other situation that, in the opinion of the investigator, may constitute a risk both for the patient and for the validity of the study. |
Los pacientes podrán ser retirados del estudio por alguna de las siguientes razones: 1.- El paciente decide no continuar en el estudio y/o con las visitas de seguimiento; 2.- El paciente no colabora o incumple el protocolo o los criterios de seguimiento. 3.- El paciente recibe algún tratamiento adicional para su condición neurológica no previsto en el protocolo. 4.- Muerte precoz u otro acontecimiento adverso grave de los recogidos en el punto 9 de este protocolo (Será comunicado inmediatamente según el procedimiento habitual). 5.- Cualquier otra situación que a criterio del investigador pueda constituir un riesgo tanto para el paciente como para la validez del estudio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Study withdrawal criteria have not been scheduled at specific timepoints |
Los criterios de retirada del estudio no han sido programados en puntos temporales concretos |
|
E.5.2 | Secondary end point(s) |
There are not secondary endpoints |
No existen criterios de retirada secundarios |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Study withdrawal criteria have not been scheduled at specific timepoints |
Los criterios de retirada del estudio no han sido programados en puntos temporales concretos |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
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 |
Itself, but in another administration shedule (standard procedure) |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
LVLS |
Última visita del último sujeto |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |