E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients bearing neuroendocrine tumour expressing somatostatin receptors refractory to conventional therapies |
Pazienti portatori di neoplasia neuroendocrina esprimente recettori per la somatostatina refrattaria ai trattamenti convenzionali |
|
E.1.1.1 | Medical condition in easily understood language |
Neuroendocrine tumour in progression after conventional therapy |
Tumore neuroendocrino in progressione dopo terapia convenzionale |
|
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052399 |
E.1.2 | Term | Neuroendocrine tumour |
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 |
Evaluation of clinical efficacy and toxicity of the tandem treatment with 177Lu-DOTA-TATE and 90Y-DOTA-TATE |
Valutazione dell'efficacia clinica e della tossicità del trattamento con 177Lu-DOTA-TATE in associazione con 90Y-DOTA-TATE |
|
E.2.2 | Secondary objectives of the trial |
Evaluation of Time to Progression (TTP) |
Valutazione del tempo alla progressione (TTP) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histopathologic diagnosis of neuroendocrine tumour; TC or MRI scan within 3 months from enrollment; Nuclear medicine imaging showing an high expression of somatostatin receptors; ECOG performance status equal or lower than 2; Age over 18 years old; Measurableor evaluable disease; Adequate medullar reserve and renal functionality; Signed informed consent. |
Diagnosi istopatologica di tumore neuroendocrino (esclusi i microcitomi); Disponibilità in formato elettronico di una CT o MRI effettuata entro 3 mesi dal reclutamento; Scintigrafia con 111In-pentetreotide (OctreoScan) o PET con analoghi della somatostatina marcati con 68Ga, dimostranti una elevata espressione dei recettori per la somatostatina; ECOG performance status inferiore a 2; Età superiore ai 18 anni; Malattia misurabile o valutabile; Adeguata riserva midollare e funzionalità renale; Consenso informato firmato dal paziente. |
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E.4 | Principal exclusion criteria |
Concomitant non neoplastc serious diseases not adequately controlled; Pregnancy or lactation; Surgery or radiotherapy within two weeks from beginning of treatment |
Presenza di gravi malattie concomitanti non neoplastiche (cardiache, renali, epatiche, metaboliche), non adeguatamente controllate o controllabili; Gravidanza od allattamento in atto; Impossibilità ad effettuare il follow up; Chirurgia e radioterapia mirata entro due settimane dall'inizio dello studio; |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of the clinical efficacy of the treatment |
Valutazione dell'efficacia clinica del trattamento |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
One year from beginning treatment |
12 mesi dall'inizio del trattamento |
|
E.5.2 | Secondary end point(s) |
Evaluation of the time to progression |
Valutazione del tempo alla progressione |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
There isn't a definided timepoint: TTP is calculated at the progression of the disease or at the death of the patient. |
Non vi è un tempo definito. Il TTP viene valutato al momento della progressione della malattia o della morte del paziente. |
|
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 | No |
E.6.5 | Efficacy | Yes |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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
|
Efficacy will be defined after 6 months from intermediate evaluation and aafter 1 year from entering the study. cronic toxicity and TTP will be evaluated at the progression of the disease |
L'efficacia verrà definita in corrispondenza della rivalutazione a 6 mesi dalla valutazione intermedia e ad 1 anno dall'inizio del trattamento. I pazienti continueranno il monitoraggio per la tossicità a lungo termine e il TTP fino alla progressione |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 42 |
E.8.9.1 | In the Member State concerned days | 0 |