Phase II Study of Neoadjuvant Chemotherapy With Dose-Dense Paclitaxel In Association With Carboplatin followed by Radical Surgery for Locally Advanced Cervical Cancer (FIGO stage IB2- IIIA) Patients.
- Conditions
- ocally Advanced Cervical CancerMedDRA version: 21.1Level: PTClassification code 10001197Term: Adenocarcinoma of the cervixSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003294-18-IT
- Lead Sponsor
- FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 46
•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 < 75 years
•Life expectancy of at least 3 months
•Written informed consent
•Ability and willingness to comply with treatment and follow up assessments and procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
•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 < 9 g/dL, neutrophils < 1500/mm3, platelets < 100000/mm3
•Impairment of renal function: creatinine > 1.5 times the upper normal limit – UNL; calculated creatinine clearance < 50 mL/min; urine protein to creatinine ratio > 1: then, a 24-hour urine protein must be assessed and subject must have a 24-hour urine protein value <1gr to be eligible
•Impairment of liver function (SGOT or SGPT > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method