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:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT02993705
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented Stage I-IV or recurrent uterine or ovarian carcinosarcoma not amenable to surgery or radiotherapy
* No more than 2 previous chemotherapy lines
* PS 0-2 (ECOG)
* Age\> 18
* Measurable disease
* Life expectancy of at least 3 months
* Adequate organ functions:
* Hematopoietic; Absolute neutrophil count ≥ 1,500/mm\^3; Platelet count ≥ 100,000/mm\^3; Hemoglobin ≥ 9 g/dL Hepatic; AST and ALT ≤ 1.5 times upper limit of normal (ULN)\*; Protocol Version 1.0\_05.09.2016 6 Alkaline phosphatase ≤ 2.5 times ULN\*; Bilirubin ≤ 1.5 times ULN NOTE: \* ≤ 3 times ULN if liver metastases are present Renal; Creatinine Clearance ≥ 45 mL/min or Serum Creatinine ≤1.5 x ULN Serum Albumin \>3.0 g/dL
* Previous Brachytherapy treatment for uterine carcinosarcoma is allowed
* No other invasive malignancy within the past 3 years except non-melanoma skin cancer
* Written Informed Consent
Exclusion Criteria:
* More than 2 previous chemotherapy lines
* Single tumor lesion inside a previous irradiated filed
* Pregnant (potentially fertile patients must be not in pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test)
* Active infection requiring antibiotics
* Symptomatic peripheral neuropathy \> grade 2 according to the NCI Common Toxicity Criteria.
* Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
* Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives
* Psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02993705
Study Brief:
Protocol Section:
NCT02993705