Comparison Of Vaginal Gauze Packing Technique With or Without Balloon In High Dose Rate Brachytherapy Of Uterine Cervical Cancer- A Crossover Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rectal and bladder radiation doses, expressed as maximum doses received to
研究概览
简要总结
This study compares vaginal gauze packing technique with or without balloon in the treatment of uterine cervical cancer using high dose rate intracavitary brachytherapy. This is a randomized controlled trial with crossover design. 36 patients will be recruited after completion of external beam radiotherapy and are eligible for intracavitary brachytherapy. They will be randomized to receive first session of brachytherapy with either the control (vaginal gauze packing alone) or experimental (combined vaginal balloon and gauze packing) techniques. For the second session of brachytherapy, patients will be crossed over. The last session of brachytherapy will not be considered as a part of the trial. CT based planning will be done and dosimetric data will be collected for the bladder and rectum. A comparison will be made for the bladder and rectal dose between the two techniques. In addition, pre and post-procedural CT scans will be done to evaluate the applicator stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients with uterine cervical cancer who have completed external beam radiotherapy and are found fit for intracavitary brachytherapy.
排除标准
- •Patients with an ECOG Performance status >
- •Patients who had undergone previous pelvic surgery.
- •Patients who had undergone previous radiation therapy.
- •Age less than 18 years.
结局指标
主要结局
Rectal and bladder radiation doses, expressed as maximum doses received to
时间窗: 1st and 2nd fractions of brachytherapy
respective organ volumes of 0.5cc,1cc and 2cc, as calculated in the CT-based
时间窗: 1st and 2nd fractions of brachytherapy
brachytherapy treatment plan.
时间窗: 1st and 2nd fractions of brachytherapy
次要结局
- Rectal and bladder radiation doses, expressed as maximum doses received to(respective organ volumes of 0.5cc,1cc and 2cc, as calculated in the CT-based)