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
||Aliza Leiser, MD
| Time frame of study:
|Location of Study:
Mount Sinai Beth Israel
St.Luke's-Mount Sinai West
Continuum Cancer Research Program
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.
• 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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