E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
124 locally advanced unresectable pancreatic cancer patients will be randomized in a 1:1 ratio to receive abraxane/gemcitabine (arm A) or gemcitabine alone (arm B), as first-line chemotherapy |
124 pazienti affetti da carcinoma pancreatico localmente avanzato, non resecabile saranno sottoposti ad una randomizzazione 1:1 a ricevere abraxane/gemcitabina (braccio A) verso la sola gemcitabina (braccio B), come terapia di I linea |
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E.1.1.1 | Medical condition in easily understood language |
locally advanced unresectable pancreatic cancer |
carcinoma pancreatico localmente avanzato, non resecabile |
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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 explore whether nab-paclitaxel in combination with gemcitabine may reduce the progression rate versus gemcitabine alone in patients with locally advanced unresectable pancreatic cancer and be worthy of further studies. |
Confrontare se l’associazione Nab-paclitaxel più gemcitabina possa ridurre il tasso di Progressione verso la Gemcitabina da sola in pazienti con carcinoma pancreatico localmente avanzato, non resecabile |
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E.2.2 | Secondary objectives of the trial |
• Quality of Response
• Safety profile
• Progression Free Survival (PFS)
Overall Survival (OS)
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• Qualità della Risposta
• Tollerabilità
• Sopravvivenza libera da malattia (PFS)
• Sopravvivenza globale (OS)
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Written informed consent
• Age < 75 years
• Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
• At least one lesion measurable with CT or MRI scan
• Performance Status (ECOG) 0-1 at study entry
• Life expectancy of at least 3 months
• Adequate marrow, liver and renal function
• Effective contraception if the risk of conception exists |
• Consenso informato scritto
• Età < 75 anni
• Diagnosi confermata istologicamente/mitologicamente di tumore del pancreas localmente avanzato, non resecabile
• Almeno una lesione misurabile con TC o RM
• Performance Status (ECOG) 0-1
• Aspettativa di vita di almeno 3 mesi
• adeguata funzionalità midollare, epatica e renale
• Adeguata copertura contraccettiva
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E.4 | Principal exclusion criteria |
• Previous chemotherapy or radiotherapy for pancreatic cancer
• CNS metastases
• Severe cardiovascular disease
• Thrombotic or embolic events
• Acute or subacute intestinal occlusion or history of inflammatory bowel disease
• Known hypersensitivity to study drug
• Known drugs or alcohol abuse
• Pregnant or breastfeeding women
• Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
• Unable to sign informed consent
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• Precedente chemioterapia o radioterapia per tumore del pancreas
• Metastasi al SNC (Sistema nervosa Centrale)
• Malattie cardiovascoari severe
• Eventi trombotici o embolici
• significative patologie gastrointestinali
• Nota ipersensibilità ad un farmaco oggetto dello studio
• Noto abuso di alcol o droghe
• Gravidanza o allattamento
• Altre neoplasie maligne, eccetto melanoma in situ o carcinoma della cervice uterina o tumori solidi trattati e con alcuna evidenza di recidiva per almeno 5 anni precedenti l’ingresso in studio
• Incapacità a fornire il consenso informato
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression rate |
Tasso di progressione |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
progression rate will be evaluated after 3 cycles of chemotherapy |
il tasso di progressione verrà valutato dopo 3 cvicli di chemioterapia |
|
E.5.2 | Secondary end point(s) |
- Quality of response
- Toxicity
- Progression Free Survival
- Overall Survival
|
- Qualità della risposta
- Tossicità
- Sopravvivenza libera da malattia
- Sopravvivenza globale |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy
- Toxicity will be analysed by treatment groups and CTCAE grade
- Progression free survival time will be defined as the time from randomization until the date of first observed disease progression or death
- Overall survival time will be defined as the time from randomization to the date of death |
- La risposta è valutata secondo i criteri RECIST alla fine della chemioterapia
- La tossicità verrà analizzata secondo il gruppo di trattamento e con i gradi CTCAE
- La progressione libera di malattia è definita dalla data di randomizzazione alla data del primo evento di recidiva o morte
- La sopravvivenza globale è definita dal momento della random alla morte |
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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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 30 |
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
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LVLS |
ultima visita dell'ultimo paziente randomizzato |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |