Clinical and Dosimetric Comparison of 2D Versus 3D HDR Brachytherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Dosimetry of Organs of genitourinary and gastrointestinal tracts
研究概览
简要总结
Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effects.
详细描述
Radiotherapy is part of a multidisciplinary strategy to fight cancer in all stages, using ionizing radiation to cause damage in tumor cells. After radical surgical treatment of gynecological tumors, pathological findings, such as extension of the myometrium invasion, histologic grade, and vascular- lymphatic invasion predict the risk of locoregional recurrence of disease and, consequently, the need for adjuvant treatment. There are two main methods of adjuvant therapy after hysterectomy for malignant neoplasm of the cervix or endometrium: external beam radiotherapy with or without booster dose of vaginal vault brachytherapy or brachytherapy alone. There are few data in the literature and clinical experience with brachytherapy dimensional (3D) for adjuvant treatment of vaginal vault .
Objective
To demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effect.
Methods: A prospective study in the Department of Radiation Oncology, Antonio Candido Camargo Cancer Center will be developed with an expected duration of 14 months and will include 60 patients. Dosimetric parameters of brachytherapy treatment of vaginal vault, able to influence the incidence of adverse effects will be evaluated. Computed tomography for planning of external beam radiotherapy and brachytherapy planning will be used, after placement of intra- vaginal applicator and urinary catheter. For planning brachytherapy two fast acquisition sequences, one with a urinary catheter not pulled and pulled another with the probe will be obtained. The prescription dose obey the standard indication of document of the International Commission on Radiation Units & Measurements (ICRU 38).
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Malignant neoplasm of the cervix or endometrium;
- •Tomography scan available in the planning system.
排除标准
- •Patients did not undergo surgery as initial treatment;
- •Patients without available tomography for planning;
研究组 & 干预措施
HDR Brachytherapy 24Gy (4 x 6Gy)
Vaginal vault brachytherapy, associated or not with external beam radiotherapy.
干预措施: 2D HDR planning (Other)
HDR Brachytherapy 24Gy (4 x 6Gy)
Vaginal vault brachytherapy, associated or not with external beam radiotherapy.
干预措施: 3D HDR planning (Other)
结局指标
主要结局
Dosimetry of Organs of genitourinary and gastrointestinal tracts
时间窗: one week after the tomograph
Dose in bladder; rectum; small intestine; sigmoid colon; urethra; dose trigone; vaginal cuff.
次要结局
- Cost analysis with local care.(6 weeks)
- Acute Genitourinary Toxicity(6 weeks)
- Acute Gastrointestinal toxicity(6 weeks)
- Late Genitourinary Toxicity(3 Years)
- Late Gastrointestinal toxicity(3 Years)
研究者
Lucas Gomes Sapienza
MD
AC Camargo Cancer Center