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
- 3
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
- •DISEASE CHARACTERISTICS:
- •Surgical randomization:
- •Histologically confirmed endometrial carcinoma
- •Disease thought preoperatively to be confined to the uterine corpus
- •Radiotherapy randomization:
- •Must have disease determined postoperatively to be confined to the uterine corpus, irrespective of pelvic node status
- •No cervical stroma invasion (stage IIB)
- •Must be macroscopically free of disease (no positive para-aortic nodes)
- •Must have high-risk disease defined as one or more of the following:
- •Grade 3 (poorly differentiated)
- •Invasion to the outer half of the myometrium (stage IC)
- •Serous papillary or clear cell type
- •Stage IIA (endocervical glandular involvement)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No other prior or concurrent malignancy likely to interfere with protocol treatment or comparisons
- •Surgical randomization:
- •Must be fit to undergo lymphadenectomy and external beam radiotherapy
- •Radiotherapy randomizations:
- •Must be fit to receive external beam radiotherapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供