Endometrial cancer is the most common gynecologic malignancy affecting American women. Women who experience the greatest risk of disease recurrence and death include those with high grade histology, deep myometrial penetration, cervical stromal involvement, and/or extrauterine disease. Patients with high risk features who have not received adjuvant irradiation have been reported to have a recurrence incidence ranging from 15-20%. Adjuvant pelvic radiation for disease confined to the uterus results in local recurrence in 0-6.5%. However, distant metastases remain a problem. At least 30% of patients with extrauterine disease who receive adjuvant involved field irradiation recur at distant sites. Because complete surgical staging is not always performed, such patients are not eligible for most national cooperative group protocols. A protocol directed at these patients has not been previously proposed. Typically these patients are treated in a variety of ways based on institutional policies founded upon individual biases or historical experiences. For this reason, it is proposed to treat patients with a demonstrated high rate of distant metastasis with both local irradiation and systemic chemotherapy. This study attempts to address a common clinical dilemma: how to manage incompletely staged patients with known high risk disease and a substantial historical incidence of distant failure despite the widespread use of adjuvant pelvic irradiation. If this trial proves feasible with acceptable toxicity, further exploration in a phase III setting will be planned.
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