Locally Advanced Cervical Cancer MedDRA version: 21.1 Level: PT Classification code 10001197 Term: Adenocarcinoma of the cervix System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: CARBOPLATINO AHCL - 10 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 15 ML
Product Name: Carboplatino AHCL
Product Code: Carboplatino AHCL
Pharmaceutical Form: Sol
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologic diagnosis of squamous cervical cancer or adenocarcinoma • Clinical diagnosis of FIGO stage IB2-IIIA at gynecological examination • ECOG Performance Status (ECOG PS): 0-1 • Age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated) • Serious heart disease, including heart failure, atrioventricular block of any degree, serious arrhythmia or history of one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA) • Hemoglobin 1.5 times the upper normal limit – UNL; calculated creatinine clearance 1: then, a 24-hour urine protein must be assessed and subject must have a 24-hour urine protein value 2.5 UNL, alkaline phosphatase > 2.5 ULN, total bilirubin > 1.5 times the UNL) • Prothrombin time (PT) or international normalized ratio (INR) or activated partial thromboplastin time (PTT) > 1.2 times the UNL • Pregnancy or breast feeding patients • Any clinical conditions which can represent a contraindications to major surgery • Localizations of disease not amenable for radical surgery • Patients' inability to access the centre due to area of residence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the dose-dense administration of paclitaxel 80 mg/mq on days 1, 8 and 15 plus carboplatin (AUC5) on day 1 every 3 weeks in terms of clinical and pathologic responses;Secondary Objective: To evaluate the tolerability of the regimen in terms of toxicity according to CTCAE Version 4.0 criteria To evaluate the Progression Free Survival (PFS) and Overall Survival (PFS) of the treated population;Primary end point(s): To evaluate the efficacy of the dose-dense administration of paclitaxel 80 mg/mq on days 1, 8 and 15 plus carboplatin (AUC5) on day 1 every 3 weeks in terms of clinical and pathologic responses;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the tolerability of the regimen in terms of toxicity according to CTCAE Version 4.0 criteria; To evaluate the Progression Free Survival (PFS) and Overall Survival (PFS) of the treated population;Timepoint(s) of evaluation of this end point: 2 years; 2 years | — |
Countries
Italy
Contacts
Public ContactS.C Oncologia Ginecologica
Fondazione IRCCS Istituto Nazionale Tumori
Outcome results
None listed