A Randomised Trial of Lymphadenectomy and of Adjuvant External Beam Radiotherapy in the Treatment of Endometrial Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,300
- 试验地点
- 6
研究概览
简要总结
RATIONALE: Lymphadenectomy may remove cancer cells that have spread to nearby lymph nodes. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether conventional surgery is more effective with or without lymphadenectomy and/or radiation therapy in treating endometrial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with or without lymphadenectomy and/or radiation therapy in treating patients who have endometrial cancer.
详细描述
OBJECTIVES:
- Compare the effects of conventional surgery alone and conventional surgery plus lymphadenectomy in patients with endometrial cancer preoperatively thought to be confined to the uterine corpus.
- Determine the effect of postoperative adjuvant external beam radiotherapy on quality of life and survival of a subset of these patients at high risk of relapse and with no macroscopic disease after surgery.
OUTLINE: This is a randomized, multicenter study. Patients are randomized in both the surgery and radiotherapy segments of the study.
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Surgery: Patients are randomized to 1 of 2 surgery arms.
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Arm I: Patients undergo conventional surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy).
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Arm II: Patients undergo conventional surgery as in arm I followed by lymphadenectomy with systematic dissection of the iliac and obturator nodes.
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Radiotherapy: Patients at high risk of relapse who have no postoperative macroscopic disease are randomized to 1 of 2 radiotherapy arms. (Patients may enter the radiotherapy randomization after surgery off study.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供