Number: GOG 258 Principal Investigator: Mutch, David
Title: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma
Phase: III Disease Site: Corpus Uteri
Participating Site(s):
Main Campus
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Patients with endometrial cancer have been treated with radiation and chemotherapy. Today most women with endometrial cancer whose cancer has spread outside the uterus generally receive chemotherapy. Women who have disease outside the uterus may also receive radiation to the areas where the disease has spread. It is not clear whether giving chemotherapy alone or together with radiation is the best treatment. This study is being conducted to determine if radiation therapy combined with chemotherapy administered for a total of 4 cycles offers a benefit over chemotherapy alone administered over 6 cycles.

The current study will compare the effects of two treatments in patients with endometrial cancer contained in the abdomen. One treatment, which is considered investigational, consists of cisplatin given together with radiation therapy followed by the drugs carboplatin and paclitaxel for 4 cycles. Another treatment, the current standard therapy, consists of carboplatin and paclitaxel given 6 cycles without radiation therapy. This study will compare survival of patients receiving these two treatments and side effects of both treatments. In this study, you will get either cisplatin plus radiation therapy followed by 4 cycles of carboplatin and paclitaxel or 6 cycles of carboplatin and paclitaxel alone. You will not get both treatments. All chemotherapy drugs used in this study are FDA approved for cancer treatment and are commonly used in the treatment of endometrial cancer.
More Information:
Internal Protocol Documents (requires Siteman administrative database password)