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 @ 7:01 PM
Ignite Modification Date:
2025-12-24 @ 7:01 PM
NCT ID:
NCT00584857
Eligibility Criteria:
Inclusion Criteria:
* Patients must have biopsy proven endometrioid adenocarcinoma or adenosquamous carcinoma.
* Patients must have evidence of primary FIGO Stage III-IVB or recurrent endometrial cancer.
* Patients with non-measurable disease following complete cytoreduction at the time of initial operative management for Stage III-IVB are eligible.
* Patients with recurrent disease must have disease confirmed by one of the following:
1. CT Scan
2. MRI
3. PET Scan
4. Physical Exam
* Patients must have adequate organ function defined as:
1. Platelets \>/= 100,000/1
2. Granulocytes (ANC) \>/= 1,500/
3. Creatinine \</= 1.6mg/dl
4. SGOT (AST) \</= 3x upper limits of normal
5. Bilirubin within institutional normal limits
* Patients must have adequate performance status (ECOG performance status 0-2.
* Patients must be age 19 or greater and have signed informed consent.
Exclusion Criteria:
* Patients with history of other malignancies (except non-melanoma skin cancer or carcinoma-in-situ of the cervix) are ineligible.
* Patients with high-risk histologic subtypes of endometrial cancer, namely papillary serous or clear cell histology are ineligible.
* Patients with evidence of uterine sarcoma, including leiomyosarcoma, carcinosarcoma, endometrial stromal sarcoma, and adenosarcoma are ineligible.
* Patients who are less than 8 weeks after the completion of radiotherapy are ineligible.
* Patients receiving any other investigational agents are ineligible.
* Patients with known hypersensitivity to paclitaxel, carboplatin, or megesterol are ineligible.
* Patients with uncontrolled current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral neuropathy, or psychiatric illness/social situations that would limit or preclude compliance with study requirements are ineligible.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT00584857
Study Brief:
Protocol Section:
NCT00584857