E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced ovarian cancer |
tumore ovarico avanzato |
|
E.1.1.1 | Medical condition in easily understood language |
advanced ovarian cancer |
tumore dell'ovaio avanzato |
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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 | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033128 |
E.1.2 | Term | Ovarian cancer |
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 |
• To explore whether clinical and biological factors, as detailed below, are able to identify a subset of patients with better prognosis in term of progression free survival (PFS) and overall survival (OS) after combined therapy with chemotherapy and bevacizumab. |
Verificare il ruolo potenziale che taluni fattori, clinici e molecolari, possono avere nell’identificare, nell’ambito di pazienti trattate con bevacizumab associato ad un regime chemioterapico, un sottogruppo a prognosi migliore, sia in termini di sopravvivenza libera da progressione (PFS) che di sopravvivenza globale (OS). |
|
E.2.2 | Secondary objectives of the trial |
• To describe the safety of bevacizumab added to carboplatin-paclitaxel chemotherapy in first line treatment of epithelial ovarian, fallopian tube and primary peritoneal cancer patients in the clinical routine practice • To investigate the prognostic value for hypertension, circulating and in-situ biomarkers for advanced epithelial ovarian, fallopian tube and primary peritoneal cancer patients treated with carboplatin-paclitaxel and bevacizumab • To describe the prevalence of use of oral antidiabetic therapy and antithrombotic therapy among the patients enrolled in the trial. |
Obiettivi secondari dello studio sono: • descrivere la sicurezza, nella comune pratica clinica, di un trattamento che combini bevacizumab e chemioterapia a base di carboplatino-paclitaxel, per la terapia di prima linea delle pazienti con carcinoma epiteliale dell’ovaio oppure carcinoma delle tube di Falloppio o per neoplasie a primitività peritoneale; • valutare il valore prognostico di ipertensione, biomarcatori circolanti e locali, per le pazienti con carcinoma epiteliale avanzato dell’ovaio oppure delle tube di Falloppio o anche neoplasie a primitività peritoneale trattate con carboplatino-paclitaxel bevacizumab; • descrivere la prevalenza dell’uso delle terapie antidiabetiche orali ed antitrombotiche fra le pazienti arruolate nello studio. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Female patients ≥18 years of age. • Patients with histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone. • FIGO stage IIIB & C or IV • ECOG Performance Status of 0–2. • Life expectancy of at least 12 weeks. • Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements. • Availability of tumour samples for molecular analyses |
• Pazienti di sesso femminile con età ≥18 anni. • Diagnosi istologica di carcinoma epiteliale dell’ovaio oppure delle tube di Falloppio o carcinoma primitivo del peritoneo, inclusi i tumori Mulleriani misti oppure • Recidiva in stadio precoce di carcinoma epiteliale dell’ovaio o delle tube di Falloppio trattata con sola chirurgia. • FIGO stadio IIIB & C o IV • Performance Status 0–2 secondo ECOG. • Aspettativa di vita di almeno 12 settimane. • Consenso informato firmato ottenuto prima dell’inizio di qualsiasi procedura studio specifica e del trattamento quale conferma della volontà della paziente di partecipare allo studio e della consapevolezza da parte della paziente di dover rispettare le procedure previste dal protocollo. • Disponibilità di campioni di tessuto tumorale per analisi molecolari. |
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E.4 | Principal exclusion criteria |
• Ovarian tumours with low malignant potential (i.e. borderline tumours) • Previous systemic anti-cancer therapy for advanced ovarian cancer. • History or evidence of brain metastases or spinal cord compression. • History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met: o stage ≤Ia o no more than superficial myometrial invasion o no lymphovascular invasion o not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma). • Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. |
• Tumori ovarici a basso potenziale di malignità (i.e. tumori borderline) • Precedente terapia antineoplastica sistemica per cancro dell’ovaio avanzato. • Storia o evidenza di metastasi cerebrali o di compressione midollare. • Storia o evidenza di carcinoma endometriale primitivo sincrono a meno che tutti i seguenti criteri per il carcinoma endometriale siano rispettati: o stadio ≤Ia o invasione miometrale solo superficiale o nessuna invasione linfovascolare o assenza di forme scarsamente differenziate (grado 3 oppure carcinoma sieroso papillare o a cellule chiare). • Altre patologie neoplastiche negli ultimi 5 anni, ad eccezione del carcinoma in situ della cervice o del carcinoma cutaneo spinocellulare o basocellulare in stadio iniziale, purché adeguatamente trattati. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at disease progression or patient death |
data della progressione o del decesso |
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E.5.2 | Secondary end point(s) |
overall toxicity |
tossicità globale |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at the end of each cycle |
alla fine di ogni ciclo |
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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 | Yes |
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) | 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 | 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
| 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 | 2 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |