CTRI/2022/03/041034招募中3 期
A prospective randomized control study to compare the effect of two dose schedules used for vault brachytherapy in intermediate risk groups of endometrial cancer.
Post Graduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年3月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- To compare the outcome (local control) of vault brachytherapy schedules of 5 Gy x 5 fractions over a week and 7 Gy in 3# in intermediate group endometrial carcinoma.
研究概览
简要总结
| Endometrial cancer is the sixth most common cancer among the females. Surgery is the mainstay of treatment and adjuvant treatment depends on the clinicopathological risk factors and the type of surgery undertaken. Endometrial cancers are stratified as low, low intermediate, high intermediate and high-risk groups. Recurrence following initial treatment appears in 10–13% of patients; >70% of failures appear in the vagina but an extra-pelvic failure can be detected in >75% of relapse. Prospective studies have demonstrated decreased local relapse with postoperative radiotherapy, either external beam radiotherapy (EBRT) or vaginal cuff brachytherapy (VCB). A wide variation of vault brachytherapy dose schedules has been noted and the studies comparing these doses are scarce. No optimal dose for VCB has been established; the reported doses for VCB alone range from 35 to 48 Gy EQD2 and 57 to 69 Gy EQD2 after EBRT. So this study will aim to compare the effect of various dose schedules used for vault brachytherapy in intermediate risk groups. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age >18 years
- •Histologically confirmed cases of Endometroid endometrial carcinoma.
排除标准
- •Poor performance status
- •Serous or clear cell carcinoma endometrium, sarcoma or carcinosarcoma
- •Stage >1, stage 1a grade 1
- •Uncontrolled Comorbidities
- •No prior history of pelvic radiotherapy
- •Residual macroscopic disease.
结局指标
主要结局
To compare the outcome (local control) of vault brachytherapy schedules of 5 Gy x 5 fractions over a week and 7 Gy in 3# in intermediate group endometrial carcinoma.
时间窗: Base line, at 3 month first followup, 6 month, 9 month, 12 month, 24 month, 36 month, 48month
To compare the toxicities of different brachytherapy schedules in endometrial cancers.
时间窗: Base line, at 3 month first followup, 6 month, 9 month, 12 month, 24 month, 36 month, 48month
次要结局
- To compare health related quality of life(To evaluate Overall survival and failure free survival)
研究者
研究点 (1)
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