E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic renal cell carcinoma (mRCC) |
CARCINOMA RENALE METASTATICO |
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E.1.1.1 | Medical condition in easily understood language |
metastatic renal cell carcinoma (mRCC) |
CARCINOMA RENALE METASTATICO |
|
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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050076 |
E.1.2 | Term | Metastatic renal carcinoma |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015411 |
E.1.2 | Term | Esophageal squamous cell carcinoma lower third stage II |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030193 |
E.1.2 | Term | Oesophageal squamous cell carcinoma upper third recurrent |
E.1.2 | System Organ Class | 100000004864 |
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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 |
Objective response rate. |
Tasso di risposte obiettive. |
|
E.2.2 | Secondary objectives of the trial |
Toxicity.
QoL.
Progression Free Survival.
Overall Survival.
|
Tossicità.
Valutazione della qualità di vita.
Sopravvivenza libera da progressione (PFS).
Sopravvivenza globale (OS).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Hystologically confirmed RCC Metastatic disease previously treated with at least three lines of different target therapy. Measurable disease (RECIST criteria 1.1). At least one metastatic site suitable for irradiation. Signed informed consent. Geographical accessibility. Age>=18 y.o. Karnofsky P.S. >= 60 (attachment 1). Life expectancy > 3 months. Adequate bone marrow function (Absolut Neutrophil count >=1,5 x 109/l, platelets>=100 x 109/l, hemoglobin >=10 g/dL). Adequate liver function: transaminases = 2.5 x upper limit of normality (ULN); bilirubin = 1.5 x ULN. Adequate renal function: Creatinine = ULN or creatinine clearance > 60 mL/min (Cockroft-Gault). Adequate contraception for childbearing potential women. Fertil men must be using adequate contraceptive measures throughout the study period and for up to 3 months after the last dose of study treatment if their partner are women of childbearing potential. Adequate cardiac function (LVEF ¿ 50% evaluated by MUGA Scan or Echocardiography and electrocardiogram)
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• Diagnosi istologica di carcinoma renale. • Malattia metastatica pretrattata con almeno tre linee di trattamento target. • Malattia misurabile secondo i criteri RECIST 1.1 . • Almeno una sede di malattia metastatica suscettibile di trattamento radioterapico. • Consenso informato scritto. • Accessibilità geografica. • Età superiore ai 18 anni. • Karnofsky Performance Status >= 60%. • Aspettativa di vita > 3 mesi. • Adeguato profilo ematologico: conta assoluta dei neutrofili (ANC) >=1,5 x 109/l, piastrine >=100 x 109/l, emoglobina >=10 g/dL. • Adeguata funzionalità epatica: transaminasi <=2,5 volte il limite superiore di normalità (ULN), bilirubina totale<=1,5 volte l’ULN. • Adeguata funzionalità renale: creatinina sierica <=ULN o clearance della creatinina calcolata (Cockroft-Gault) > 60 mL/min. • Le donne in età fertile devono usare un metodo contraccettivo adeguato. Gli uomini fertili, se le loro partner sono in età fertile, devono usare un metodo contraccettivo adeguato durante tutto lo studio. • • Adeguata funzionalità cardiaca (frazione di eiezione > 50 %, valutata con MUGA scan o ecocardiogramma ed ECG)
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E.4 | Principal exclusion criteria |
History of malignant disease (with the exception of non-melanoma skin tumours) in the preceding five years.
Prior organ transplantation.
Brain metastasis
Autoimmune or allergic disorders
Previous HBV and/or HCV infections
Prior treatment with IL-2.
Active steroid therapy
Any active infection requiring specific treatment (Antibiotics, antimicotic, antiviral)
Radiotherapy within 6 weeks before enrollment.
Pregnant or lactating females.
Other non-malignant uncontrolled systemic diseases or social conditions that would preclude trial entry in the opinion of the investigator.
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• Pregresse neoplasie maligne d'altra origine nei precedenti 5 anni (esclusi tumori della cute, non melanoma) .
• Trapianti d'organo.
• Metastasi cerebrali.
• Patologia autoimmune o patologia allergica.
• Pregresse infezioni da HBV e/o HCV.
• Pregresso trattamento con IL2.
• Trattamento attivo con cortisonici.
• Malattia infettiva in atto che necessita di terapia specifica (antibiotica, antivirale o antimicotica).
• Radioterapia nelle 6 settimane precedenti l’arruolamento.
• Donne incinte o in allattamento.
• Presenza di altra condizione non oncologica non controllata o condizioni sociali che precludano l’entrata in studio nell’opinione del clinico.
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective response rate. |
Tasso di risposte obiettive. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Toxicity.
QoL.
Progression Free Survival.
Overall Survival.
; Toxicity; QoL; Progression Free Survival; Overall Survival |
Tossicità.
Valutazione della qualità di vita.
Sopravvivenza libera da progressione (PFS).
Sopravvivenza globale (OS).
; Tossicità; Valutazione della qualità di vita ; Sopravvivenza libera da progressione; Sopravvivenza globale |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
UNTIL DEATH; During treatment and during 4 weeks after end of treatment; Every cicle and end of treatment; From study entry to first documented disease progression or death from any cause wichever occurred first; From study entry to death from any cause |
FINO A DECESSO; Durante il trattamento e nelle 4 settimane successive al termine del trattamento; Ad ogni ciclo e a fine trattamento; Dall'entrata in studio al primo riscontro di progressione di malattia o morte per qualsivoglia causa; Dall'entrata in studio e la morte per qualunque causa |
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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 | 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 | No |
E.8.1.2 | Open | No |
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 | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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
|
DEATH OF ALL ENROLLED PATIENTS |
DECESSO DI TUTTI I PAZIENTI ARRUOLATI |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 36 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 36 |
E.8.9.2 | In all countries concerned by the trial days | 0 |