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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT02681432
Eligibility Criteria:
Inclusion Criteria:
* Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test)
* Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))
* No extra-abdominal tumor disease
* Absence of heart failure. Adequate renal and hepatic functions
* Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
Exclusion Criteria:
* Patients with unresectable tumor or incomplete cytoreduction.
* Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count \<1.500/mm3 (\<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections.
* Extra-abdominal metastases or unresectable liver metastases
* Presence of other malignant tumor disease.
* Multisegmental complete bowel obstruction.
* Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk
* Patients who refuse treatment or consent to participate in study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02681432
Study Brief:
Protocol Section:
NCT02681432