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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03275194
Eligibility Criteria:
Inclusion Criteria:
1. Patients younger than 70 years
2. Patient with a diagnosis of high grade serous carcinoma of the ovary and low-grade endometrioid corroborated by histopathological study.
3. Clinical stage IIIC and IVA (cytology-positive pleural effusion) who have received induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL.
4. Partial response to treatment with chemotherapy and evaluated by computed tomography (RECIST-see below) and response of at least 50% by serum determination of CA-125 antigen.
5. Signature of informed consent.
6. Optimal cytoreduction with residual tumor less than 2.5 mm during interval surgery
7. ECOG less than or equal to 1
8. Adequate renal, cardiac, hepatic, bone marrow and lung function evaluated preoperatively with the following parameters:
a) Hb equal to or greater than 10 g / L (pre-treatment transfusion is permitted to achieve this hemoglobin level) b) Leukocytes Greater than 3000 / mm3 (c) Platelets equal to or greater than 100 000 / mm3 (d) total bilirubin less than 1.5 times greater than the normal value e) Hepatic transaminases less than 1.5 times higher than normal value f) Creatinine \<1.2 g / dl. In case of being elevated the measured purification should be greater than 60mL / min according to Cockroft's formula.
g) Albumin greater than 3gr / dl. h) Left Ventricle Ejection fraction per cardiac echography greater than 55% 9). Sugarbaker carcinomatosis index less than 20
Exclusion Criteria:
1. Patients with heart failure, ischemic heart disease
2. Previous history of treatment with chemotherapy for some other neoplasia
3. History of neuropsychiatric disease
4. Patients with intra operative bleeding that condition hemodynamic instability.
5. Patient requiring more than 2 intraoperative anastomosis
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03275194
Study Brief:
Protocol Section:
NCT03275194