A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging
- Before chemotherapy, patients will receive extra fluid by IV for 2 hours, and will be
given medicine to prevent side effects from the chemotherapy drugs.
- Chemotherapy treatments will be given intravenously in the outpatient clinic. Patients
will receive IV paclitaxel/carboplatin chemotherapy every 21 days for 3 cycles.
- After 3 cycles of chemotherapy, patients will receive external beam radiotherapy.
Radiation will be delivered to the patient's pelvis at the dose prescribed by the
- External radiation will be given once a day, five days a week (Monday-Friday) for 5
- Patients will then receive internal high-dose radiation, which will be given once a
week for three weeks. This type of radiation is given through a vaginal cylinder, a
device that is inserted in the vagina that directs the radiation to your tumor. It is
a procedure that is done with anesthesia.
- The 4th cycle of chemotherapy will overlap with the high dose radiation.
- The remainder of the planned 6 cycles of paclitaxel/carboplatin therapy will continue
to be administered every 21 days.
- Prior to and during the study, tests and procedures will be performed; including
physical examinations, routine blood tests, urine tests, ECG, medical history and vital
signs, radiologic examinations.
- The study treatment will proceed as long as the tumor does not grow and the patient
isn't experiencing any severe side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess and document location of disease recurrence (distant vs. local. vs. both) using this treatment regimen.
Dennis Yi-Shin Kuo, MD
Montefiore Medical Center
United States: Institutional Review Board
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