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临床试验/NCT00542490
NCT00542490已完成2 期

Phase II Trial of Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy in Patients With Stage I-IIb Papillary Serous, Clear Cell and Endometrioid Endometrial Cancer With High-Intermediate Risk Factors

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
23
试验地点
2
主要终点
Number of Patients With Progression-free Survival at 2 Years

研究概览

简要总结

The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.

详细描述

All patients must have undergone complete surgical staging including bilateral pelvic and para-aortic lymphadenectomy. All patients will receive radiation therapy. Treatment will be delivered either by LDR or HDR brachytherapy. The treatment plan must be started at the time of enrollment. The vaginal brachytherapy should be started within 4 weeks of surgery (within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy, which should start on post-operative day 21. The dose will be prescribed to the vaginal (mucosal) surface as defined at the surface of the applicators. Following vaginal cuff radiation therapy, all patients will receive chemotherapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients must have undergone specified complete surgical staging.
  • Patients must be surgically staged endometrial cancer patients at high-risk for recurrence.
  • Patients must have adequate bone marrow, renal and hepatic function.

排除标准

  • Patients with recurrent disease.
  • Patients with GOG performance status of 3 or 4.

结局指标

主要结局

Number of Patients With Progression-free Survival at 2 Years

时间窗: 2 years

次要结局

  • Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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