GOG-0258: 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

Summary:
For patients with endometrial cancer 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 for 6 cycles without radiation therapy. This study will compare survival of subjects receiving these two treatments and side effects of both treatments.

Eligibility and Treatment Plan:

• All patients must have undergone hysterectomy and bilateral removal of fallopian tubes and ovaries.
• Patients with Surgical Stage III endometrial cancer, including clear cell and serous papillary and undifferentiated carcinomas.
• Patients with Surgical Stage IVA endometrial carcinoma with bladder or bowel mucosal involvement, but no spread outside the pelvis.
• Patients with Stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology.

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