E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
NEWLY DIANGOSED GLIOBLASTOMA ELDERLY PATIENTS |
PAZIENTI ANZIANI AFFETTI DA GLIOBLASTOMA DI NUOVA DIAGNOSI |
|
E.1.1.1 | Medical condition in easily understood language |
NEWLY DIANGOSED GLIOBLASTOMA ELDERLY PATIENTS |
PAZIENTI ANZIANI AFFETTI DA GLIOBLASTOMA DI NUOVA DIAGNOSI |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018337 |
E.1.2 | Term | Glioblastoma multiforme |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018336 |
E.1.2 | Term | Glioblastoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
Assessment of neurocognitive function in elderly patients (= 70 years) with GBM treated with RT or hypofractionated TMZ as single agent |
Valutazione della funzione neurocognitiva in pazienti anziani (età = 70 anni) con GBM trattati con RT ipofrazionata o TMZ come singolo agente |
|
E.2.2 | Secondary objectives of the trial |
1. Overall survival 2. Evaluation of quality of life 3. Evaluation of tolerance to treatment
|
- sopravvivenza globale - Valutazione della qualità della vita - Valutazione della tolleranza al trattamento
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. = 70 years 2. Karnofsky Performance Score (KPS) = 60 3. Newly diagnosed GBM intracranial histologically confirmed after biopsy or resection no more than 4-6 weeks prior to treatment; 4. Adequate bone marrow function (WBC = 3000 / ul, absolute neutrophil count = 1500 / ul, platelet count = 100,000 / mm3, and hemoglobin = 9 g / dL), hepatic (AST and ALT <3 times the upper value normal, and serum bilirubin <2 mg / dL), and renal function (creatinine <1.5 mg / dL or calculated creatinine clearance> 50 / mL / min) before starting therapy 5. Informed consent
|
- = 70 anni; - Karnofsky Performance Score (KPS) = 60; - GBM intracranico di nuova diagnosi confermato da biopsia o resezione non più di 4 settimane prima del trattamento; - adeguata funzionalità del midollo osseo (WBC = 3000/µL, conta assoluta dei neutrofili = 1500/µL, conta delle piastrine = 100.000/mm3, e emoglobina = 9 g/dL), epatica (AST e ALT < 3 volte il valore superiore normale, e bilirubina sierica < 2 mg/dL), e renale (creatinina < 1.5 mg/dL, o clearance della creatinina calcolata > 50/mL/min) prima di iniziare la terapia - consenso informato |
|
E.4 | Principal exclusion criteria |
Presence of psychiatric disorders that may interfere with the feedback or neuro cognitive understanding of informed consent. |
presenza di patologie psichiatriche che potrebbero interferire con le valutazioni neuro cognitive o con la comprensione del consenso informato. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Hopkins Verbal Learning Test-Revised (HVLT-R), item "Total Recall", after 6 months of treatment |
deterioramento neuro cognitivo valutato con il Hopkins Verbal Learning Test-Revised (HVLT-R) , item “Total recall”, dopo 6 mesi di trattamento |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; TOXICITY (CTC) |
SOPRAVVIVENZA GLOBALE ; TEMPO LIBERO DA PROGRESSIONE; TOSSICITA' MEDIANTE CTC |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
DEATH OR TWO YEARS FOLLOW-UP; DEATH OR PROGRESSION; MONTHLY |
DECESSO O DUE ANNI DOPO L'ARRUOLAMENTO DELL'ULTIMO PAZIENTE; PROGRESSIONE O DECESSO; MENSILMENTE |
|
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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
COGNITIVE FUNCTION EVALUATION |
VALUTAZIONE FUNZIONI COGNITIVE |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 |
RADIOTERAPIA |
RADIOTHERAPY |
|
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 | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
|
|
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 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 |