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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT00231868
Eligibility Criteria:
Inclusion Criteria:
1. Histologically documented uterine papillary serous carcinoma (UPSC) with no visible residual disease.
2. Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings.
3. Age \> 18 years.
4. ECOG performance status of \< 2.
5. Written voluntary informed consent.
Exclusion Criteria:
1. Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:
1. Serum SGOT and /or SGPT \> 2.5 times the institutional upper limit of normal
2. Total serum bilirubin \> 1.5 mg/dl
3. History of chronic or active hepatitis
4. Serum creatinine \> 2.0 mg/dl
5. Platelets \< 100,000/mm3
6. Absolute neutrophil count (ANC) \< 1500/mm3
7. Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry)
2. Patient has severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
3. Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry.
4. Patient with any prior chemotherapy or radiotherapy for pelvic malignancy.
5. Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00231868
Study Brief:
Protocol Section:
NCT00231868