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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT02973750
Eligibility Criteria:
Inclusion Criteria:
* Participants must have one of the following: a) Histological or cytological diagnosis of high-grade serous ovarian, fallopian, or peritoneal cancer, stage III or IV; b) In the opinion of investigator, highly suspicious stage III or IV ovarian, fallopian, or peritoneal cancer (histologically confirmed non-serous ovarian, fallopian, and peritoneal cancers will be considered screening failures).
* At least one biopsiable lesion by CT/US or laparoscopy.
* Have not received previous treatment for ovarian cancer.
* Life expectancy of greater than 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status \<3 (Karnofsky \>60%).
* Must have adequate organ and marrow function.
* Deemed eligible for neo-adjuvant chemotherapy with carboplatin and paclitaxel and surgery by their oncologist.
* Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Active second malignancy within last 2 years (except non-melanoma skin cancer or in situ carcinomas.
* Prior treatment for ovarian cancer.
* Potential participants with known brain metastases will be excluded from this clinical trial.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin and paclitaxel.
* Known allergy to carboplatin, paclitaxel, or cremophor.
* Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Women who are pregnant. Breastfeeding should be discontinued if the mother is treated with carboplatin and paclitaxel. These potential risks may also apply to other agents used in this study.
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin and paclitaxel or other agents administered during the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02973750
Study Brief:
Protocol Section:
NCT02973750