Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment
研究概览
简要总结
This trial is assessing how Bladder filling variations and thus mesorectal movements are less when radiotherapy treatment is received with an empty bladder in rectal cancer
详细描述
The purpose of this study is to show that the variations of bladder volume and mesorectal movements are less with empty versus filled bladder in rectal cancer.
In this study, patient will be treated with 3D conformal radiotherapy (3D-CRT) radiotherapy with a filled bladder condition, as per standard care, in supine position. A total dose of 45 or 50 Gy in 25 fractions, 5 fractions per week is received.
A Chest, abdomen and pelvis imaging will be performed before treatment start. Patients receive planning CT scan (pCT) with filled bladder and then with empty bladder on the same day. Only pCT with filled bladder will be used patient treatment.
During radiotherapy treatment, patient will receive Cone beam CT (CBCTs) with filled ans empty bladder on Day 1 ; 2 and 3 on the first week and once a week after.
Multiple parameters will be assessed before treatment (using pCT) and during radiotherapy treatment (CBCTs) in empty ans filled bladder conditions : Bladder volume, mesorectal movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed rectal adenocarcinoma
- •T2 N+ or T3 any N, eligible for radiotherapy or neo-adjuvant radio-chemotherapy treatment in a long course of 25 fractions
- •Performance Status less or equal to 2
- •Male or female 18 Years and older
- •Creatinine clearance greater than or equal to 50ml/min
- •Fertile patients must use effective contraception
- •Written informed consent
- •Patient must be affiliated to a Social Health Insurance
排除标准
- •Previous treatment with pelvic radiotherapy
- •Chronic inflammatory bowel disease in flare-up.
- •Urinary catheterization, urinary diversion or cystectomy
- •Hip prosthesis
- •History of prostatectomy, or hysterectomy
- •Urinary incontinence > 2
- •Pregnant or nursing patient
- •Persons deprived of their liberty, as well as adults subject to a legal protection measure
- •Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons
结局指标
主要结局
Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment
时间窗: 3.5 years
Throughout the radiotherapy treatment, the reproducibility of positioning of the anterior surface of mesorectum will be assessed with empty and filled bladder
次要结局
- IMRT (Intensity-Modulated Radiotherapy) dosimetric study in patients with filled or empty bladder(3.5 years)
- Evaluate mesorectal movements during radiotherapy in empty versus filled bladder(3.5 years)
- Evaluate changes in bladder volume during radiotherapy in empty versus filled bladder(3.5 years)