Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT03220932
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed platinum-resistant Epithelial Ovarian Carcinoma (EOC)(clinical recurrence or persistence within 6 months of last treatment);
* White blood cells \>3,500/mm3, neutrophils ≥1,500/mm3, platelets ≥100,000/mm3;
* Good renal function: serum creatinine values \<1.5 mg/dl, creatinine clearance \>60 ml/min;
* Performance Status ≤2, Karnofsky Index ≥70%;
* Serum bilirubin ≤1.5 x Upper limit of normal (UNL) 2 mg/dl;
* Prior ovarian surgery before starting study treatment;
* Covered by a Healthcare System, where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research;
* Signed written informed consent obtained prior to any study-specific screening procedures.
Exclusion Criteria:
* Platinum-refractory EOC (i.e progression under platinum containing chemotherapy);
* Any prior malignancy not considered in complete remission for at least 2 years;
* Pregnancy or breastfeeding;
* Untreated central nervous system disease or symptomatic central nervous system metastasis, history or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment;
* Uncontrolled hypertension or active clinically significant cardiovascular disease;
* Females of childbearing age not using medically accepted contraceptive measures, as judged by the investigator;
* Contraindication to any drug contained in the chemotherapy regimen;
* Known contraindication to cisplatin
* Medical, geographical, sociological, psychological or legal conditions that would prevent the patient from completing the study or signing the informed consent;
* Any significant disease which, in the investigator's opinion, excludes the patient from the study;
* Under any administrative or legal supervision.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03220932
Study Brief:
Protocol Section:
NCT03220932