Status:
COMPLETED
A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma
Lead Sponsor:
Montefiore Medical Center
Conditions:
Uterine Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of...
Detailed Description
Uterine papillary serous carcinoma (UPSC) is an uncommon, but aggressive variant of endometrial carcinoma that has a high recurrence rate and poor response to therapy. It has a propensity to metastasi...
Eligibility Criteria
Inclusion
- Histologically documented uterine papillary serous carcinoma (UPSC) with no visible residual disease.
- Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings.
- Age \> 18 years.
- ECOG performance status of \< 2.
- Written voluntary informed consent.
Exclusion
- 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
- Total serum bilirubin \> 1.5 mg/dl
- History of chronic or active hepatitis
- 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)
- Patient has severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
- Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry.
- Patient with any prior chemotherapy or radiotherapy for pelvic malignancy.
- 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 :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00231868
Start Date
December 1 2001
End Date
July 1 2011
Last Update
August 12 2020
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10461