A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Carcinoma
The purpose of this study is to determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to pelvic radiation therapy.
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Participants may be eligible if they have had a hysterectomy and bilateral salpingo-oophorectomy. They must have high-risk, early stage endometrial carcinoma and have adequate bone marrow, renal, hepatic and neurologic function.
You will be assigned by chance to one of the following treatments: Participants in Treatment #1 will receive the current standard treatment, which is pelvic radiation therapy over five – six weeks. They may receive additional radiation therapy at the physician’s discretion. Participants in Treatment #2 will receive a different form of radiation therapy, called brachytherapy, along with chemotherapy. Treatment #2 will last at least nine weeks.
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