Ovarian Cancer Clinical Trial
— EXPERTOfficial title:
EXemestane in Progesterone and/or Estrogen Receptor Positive Epithelial Ovarian Cancer: A Randomized Phase III Trial, EXPERT
Verified date | February 2024 |
Source | Ente Ospedaliero Ospedali Galliera |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment. The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS).
Status | Terminated |
Enrollment | 23 |
Est. completion date | April 27, 2023 |
Est. primary completion date | April 27, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - Citologically or histologically confirmed high grade serous or endometrial epithelial ovarian cancer, including cancer of fallopian tube and peritoneum. For patients who are candidates for neoadjuvant chemotherapy, diagnosis must be documented via imaging or a core tissue (not fine needle aspiration) biopsy. - Disease stage IIB to IV according to FIGO classification. For patients who are candidates for neoadjuvant chemotherapy, stage IIB-IV should be documented via imaging or a core tissue (not fine needle aspiration) biopsy. - Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy. For patients enrolling after debulking surgery, randomization should occur at a maximum of 12 weeks and not before 4 weeks after surgery. - Immunoistochemically determined positivity (= 10%) for Progesterone and/or Estrogen receptor expression, including determination on cytology smears from ascitic fluid if surgery is differed. - Measurable or evaluable disease confirmed by radiological imaging, or histological proven ovarian cancer in the absence of postoperatively measurable or evaluable lesions - Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2. - Written, informed consent obtained prior to any study-specific procedures. Exclusion Criteria: - Previous systemic therapy for ovarian cancer. - 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. - Inadequate bone marrow, hepatic or renal functions, assessed within 7 days prior to randomization. - Treatment with hormonal contraceptives during the previous 3 months from diagnosis. - Concurrent comorbidities, which contraindicates the administration of chemotherapy, or endocrine therapy. - Pregnant or lactating patients. - Inability or unwillingness to swallow tablets. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Sanitaria Locale CN2 | Alba | CN |
Italy | AO SS Antonio e Biagio e Cesare Arrigo | Alessandria | AL |
Italy | CRO Centro di Riferimento Oncologico | Aviano | PN |
Italy | Ospedale Oncologico IRCCS Bari | Bari | BA |
Italy | Ospedale degli Infermi | Biella | BI |
Italy | Azienda Ospedaliero Universitaria Policlinico S.Orsola-Malpighi | Bologna | BO |
Italy | ASST degli Spedali Civili di Brescia | Brescia | BS |
Italy | Fondazione Poliambulanza | Brescia | BS |
Italy | AOU Cagliari, Policlinico Universitario | Cagliari | CA |
Italy | Fondazione del Piemonte per l'Oncologia - IRCCS | Candiolo | TO |
Italy | ARNAS Garibaldi | Catania | CT |
Italy | Azienda Ospedaliera per l'emergenza Cannizzaro | Catania | CT |
Italy | Ospedale Policlinico "SS. Annunziata" | Chieti | CH |
Italy | Ospedale Sant Anna di Como | Como | CO |
Italy | Azienda Ospedaliera S.Croce e Carle | Cuneo | CN |
Italy | Ospedale "degli Infermi" | Faenza | RA |
Italy | AULSS 1 Dolomiti - Ospedale "Santa Maria del Prato" | Feltre | BL |
Italy | ASL 3 Ospedale Villa Scassi | Genova | GE |
Italy | IRCCS AOU San Martino - IST | Genova | GE |
Italy | Medical Oncology Division, Ente Ospedaliero Ospedali Galliera | Genova | |
Italy | Ospedale "Vito Fazzi" | Lecce | LE |
Italy | ASST Lecco - Ospedale "A. Manzoni" | Lecco | LC |
Italy | Ospedale "Umberto I" | Lugo | RA |
Italy | Presidio Ospedaliero Unico Av3 | Macerata | MC |
Italy | Ospedale di Manerbio | Manerbio | BS |
Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS | Meldola | FC |
Italy | Istituto Europeo di Oncologia (IEO) | Milano | MI |
Italy | AOU Policlinico di Modena | Modena | MO |
Italy | Ospedale di Mondovì CN1 | Mondovì | CN |
Italy | UOS Oncologia Ginecologica, Ospedale S. Gerardo | Monza | MB |
Italy | Istituto Nazionale Tumori - IRCCS "Fondazione G.Pascale" | Napoli | |
Italy | Azienda Ospedaliero-Universitaria Maggiore della Carità | Novara | |
Italy | A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli | Palermo | PA |
Italy | Fondazione IRCCS Policlinico San Matteo | Pavia | PV |
Italy | Ospedale "Guglielmo da Saliceto" | Piacenza | PC |
Italy | Azienda Ospedaliero-Universitaria Pisana | Pisa | PI |
Italy | Azienda Ospedaliera Regionale San Carlo | Potenza | PZ |
Italy | Ospedale Santa Maria delle Croci | Ravenna | RA |
Italy | Azienda Ospedaliera Arcispedale Santa Maria Nuova | Reggio Emilia | RE |
Italy | Policlinico Umberto I, Università di Roma "La Sapienza" | Roma | RM |
Italy | Policlinico Universitario Fondazione Agostino Gemelli | Roma | RM |
Italy | Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | FG |
Italy | Azienda Ospedaliero Universitaria di Sassari | Sassari | SS |
Italy | ASST Valtellina e Alto Lario | Sondrio | SO |
Italy | AO Ordine Mauriziano | Torino | TO |
Italy | Azienda Ospedaliero-Universitaria Città della Salute e della Scienza - Ospedale Ostetrico Ginecologico Sant'Anna | Torino | TO |
Italy | Presidio Ospedaliero S. Andrea | Vercelli | VC |
Lead Sponsor | Collaborator |
---|---|
Ente Ospedaliero Ospedali Galliera | Federation of Italian Cooperative Oncology Groups, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Istituto Di Ricerche Farmacologiche Mario Negri |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Circulating and tissue biomarkers | To collect and store blood and tissue samples to create a bio-bank for the assessment of circulating and tissue biomarkers with potentially prognostic/predictive value, including the androgen receptor (AR) expression and the generation of a somatic genomic and transcriptomic atlas of epithelial ovarian cancers, to map the different molecular vulnerabilities lagging behind the single definition of each histological subtype. Data generated will allow to select molecular biomarkers with prognostic/predictive relevance, to have information of patients risk of relapse or to guide novel treatment approaches.
These biomarker endpoints will be considered in a second phase of the study, if additional funds are available to perform the analyses. |
Up to 20 months | |
Primary | Progression free survival (PFS) | PFS id defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, second primary malignancy or death from any cause, whichever comes first. Patients not recurred, progressed or died while on study or lost to follow-up will be censored at their last disease assessment date. | Up to 20 months | |
Secondary | Overall survival (OS) | OS is defined for each patient as the time from the date of randomization to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. | Up to 20 months | |
Secondary | Objective Response Rate (ORR) | ORR is defined as the number of patients who will experience a complete or partial response divided by the number of patients randomized with at least one target lesion at baseline. Each patient will be assigned the best response ever recorded during the trial | a CT-scan will be performed every 4 months. Up to 20 months from last patients randomized | |
Secondary | Quality of Life: Menopause Quality of Life (MENQoL) questionnaire | The effect of study treatment will be assessed based on the MENQOL intervention questionnaire based on 29 items divided in four domains (vasomotor, physical, psychosocial and sexual), each scored from 1 to 8 (1 means no symptom, 2 presence of the symptoms but not bothersome, 3-8 an increasing grade of discomfort). Mean changes from the baseline domain scores between treatment arms will be evaluated. | Up to 20 months | |
Secondary | Compliance - Number of administered cycles | Number of administered cycles | Up to 20 months | |
Secondary | Compliance - Reasons for discontinuation and treatment modification | Number of patients for each reasons | Up to 20 months | |
Secondary | Compliance - Dose intensity | Number of tablets taken (i.e., number of tablets given-number of tablets returned)/number of tablets that should have been taken during the treatment period. | Up to 20 months | |
Secondary | Safety (Adverse Events) | Maximum toxicity grade experienced by each patient for each toxicity, proportion of patients experiencing grade 3-4 toxicity for each toxicity, type, frequency and nature of serious adverse events (SAEs).
Proportion of patients with at least one SAE. Proportion of patients with at least one serious adverse drug reaction (SADR). |
Up to 20 months |
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