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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Uterine Cancer
Location: United States, NY

Clinical Trial Details

Overview

Research Study Summary

A Pilot Trial of Radiation Therapy "sandwiched" between Paclitaxel and Carboplatin in Patients with Uterine Carcinosarcoma

Purpose

The purpose of this study is to determine whether radiation therapy "sandwiched" between paclitaxel/carboplatin chemotherapy is effective in the treatment of uterine carcinosarcoma,and particularly whether this treatment will lessen the chance of the cancer returning in the pelvis or elsewhere in the body.

Patient Inclusion Criteria:

  • Histologically documented uterine carcinosarcoma with no visible residual disease.
  • Surgical staging to include total abdominal hysterectomy, bilateral salpingo- oophorectomy, peritoneal washings, and lymph node samplings.
  • Patients must be entered no more than 12 weeks post operatively.
  • Age > 18 years.
  • ECOG performance status of < 2.
  • Written voluntary informed consent

Patient Exclustion Criteria:

  • 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 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.

To Learn more
Phase

2

Gender

Female

Age

18 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

Loraine Centrilla, RN, Research Coordinator
The Harold & Muriel Block Institute for Clinical and Translational Research at Einstein & Montefiore
Montefiore Medical Center
1695 Eastchester Road Suite 601
Bronx, NY 10461
Phone: 718-405-8082

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 176618

Date Last Changed: April 14, 2014


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