Status:
WITHDRAWN
Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation
Lead Sponsor:
Northwell Health
Conditions:
Uterine Carcinoma
Eligibility:
FEMALE
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
Uterine serous carcinoma (USC) is an uncommon, but aggressive variant of endometrial carcinoma that has poor response to standard therapy. After staging and surgery, radiation therapy and/or chemother...
Detailed Description
TREATMENT PLAN 5.1 Dosing Guidelines 5.1.1 Chemotherapy Paclitaxel is available commercially. Paclitaxel 135mg/m2 will be given over 1 hour in 250-500 ml of 5% dextrose or normal saline. Premedication...
Eligibility Criteria
Inclusion
- Histological/cytologically documented primary FIGO Stage IIIA, IIIB, IIIC1, IIIC2, IVA and IVB uterine serous carcinoma. Patients with stage IVB disease include abdominal sites of metastasis only.
- All patients must have a procedure for determining the definitive diagnosis of USC. At the discretion of the surgeon, complete surgical staging should include: total hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, omental biopsy and lymph node evaluation.
- Residual disease at completion of surgery of ≤ 1cm by surgeon report.
- Age \> 18 years.
- ECOG performance status of ≤ 2.
- Written voluntary informed consent.
Exclusion
- Distant metastasis outside the abdominal cavity.
- Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:
- Serum SGOT and /or SGPT \> 2.5 times the institutional upper limit of normal (ULN)
- Total serum bilirubin \> 1.5 mg/dl
- Serum creatinine \> 2.0 mg/dl
- Platelets \< 100,000/mm3
- Absolute neutrophil count (ANC) \< 1500/mm3
- Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry)
- History of abdominal/pelvic radiation therapy.
- Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
- Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04030000
Start Date
May 20 2020
End Date
January 30 2023
Last Update
March 17 2023
Active Locations (1)
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1
Arisa Kapedani
New Hyde Park, New York, United States, 11040