A Randomised Phase II Trial of Adaptive Image Guided Standard or Dose Escalated Tumour Boost Radiotherapy in the Treatment of Transitional Cell Carcinoma of the Bladder
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 345
- 试验地点
- 49
- 主要终点
- Proportion of participants meeting predefined radiotherapy dose constraints in DART group
研究概览
简要总结
Bladder cancer is the seventh most common cancer in the UK, with 10,399 new cases diagnosed in 2011. In a quarter of these cases the cancer has infiltrated the muscular wall of the bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually treated either with surgical removal of the bladder, or daily radiotherapy treatment (high strength xrays which kill cells), given every day for 4 or 7 weeks. RAIDER will investigate methods which have the potential to improve how well this radiotherapy works.
RAIDER is based on a study of novel radiotherapy techniques which was conducted at a single UK NHS Trust. Bladder radiotherapy is normally delivered using a single plan throughout treatment and treats the whole bladder with the same radiotherapy dose. In adaptive radiotherapy the delivery plan is chosen from 3 possible plans. In cancer (tumour) focused radiotherapy, the highest dose of the radiotherapy is aimed at the tumour within the bladder.
In RAIDER, at least 240 participants with muscle invasive bladder cancer will be in one of 3 treatment groups:
- standard whole bladder radiotherapy
- standard dose tumour focused adaptive radiotherapy
- dose escalated tumour boost adaptive radiotherapy
Participants will visit the hospital 4 weeks, 3, 6, 9, 12, 18 and 24 months after radiotherapy and annually thereafter to check whether the cancer has returned and to receive treatment for any symptoms they may be experiencing.
RAIDER aims to confirm in a multicentre setting that novel techniques allow a higher radiotherapy dose than standard to be reliably targeted at the tumour within the bladder and to check that the long term side effects of the treatment are acceptable. If this is the case, results of RAIDER will be used to develop a study to establish whether dose escalated radiotherapy is better at treating bladder cancer than standard dose.
详细描述
RAIDER has a two stage design. Stage 1 will establish the feasibility of delivering DART in a multi-centre setting, and stage 2 will establish the toxicity of DART. 72 patients will be recruited in stage 1, with at least an additional 168 patients in stage 2 (sufficient to recruit 57 evaluable participants to the DART group in each fractionation cohort).
Both fractionation regimens in standard use in UK are included - 32f and 20f. Participants will be permitted to receive concomitant chemotherapy. Primary endpoints will be assessed in each fractionation cohort separately with the flexibility to drop either a fractionation cohort or an experimental treatment group (on advice of Independent Data Monitoring Committee) following completion of stage 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age ≥16 years
- •Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder
- •Unifocal bladder TCC staged T2-T4a N0 M0*
- •Fit to receive a radical course of radiotherapy
- •WHO performance status 0-2
- •Willing and able to comply with study procedures and follow up schedule *Tumour location must be clearly visible on imagine or recorded on a surgical bladder map
排除标准
- •Nodal or metastatic disease
- •Multifocal invasive disease
- •Simultaneous TCC in upper tract or urethra
- •Pregnancy
- •Active malignancy within 2 years of randomisation (not including non melanomatous skin carcinoma, previous non muscle invasive bladder tumours, NCCN low risk prostate cancer (T1/T2a, Gleason 6 PSA <10), in situ carcinoma of any site)
- •Bilateral hip replacements
- •Any other conditions that in the Principal Investigator's opinion would be a contra-indication to radiotherapy (e.g. previous pelvic radiotherapy / inflammatory bowel disease)
研究组 & 干预措施
WBRT
Standard dose whole bladder radiotherapy
干预措施: WBRT (Radiation)
SART
Standard dose Adaptive tumour focused radiotherapy (SART)
干预措施: SART (Radiation)
DART
Dose escalated Adaptive tumour boost radiotherapy (DART)
干预措施: DART (Radiation)
结局指标
主要结局
Proportion of participants meeting predefined radiotherapy dose constraints in DART group
时间窗: 4-6 weeks from randomisation
Primary outcome of stage 1 of study, predefined radiotherapy dose constraints for bladder, bowel and rectum met for medium plan in DART group.
Proportion of patients experiencing severe late side effects following radiotherapy.
时间窗: 6-18 months post radiotherapy
Primary outcome of stage 2 of study, late CTC toxicity grade 3 or higher.
次要结局
- Patient reported outcomes- symptomatic toxicity(0-24 months post radiotherapy)
- Patient reported outcomes- urinary side effects(0-24 months post radiotherapy)
- Patient reported outcomes- chronic gastrointestinal symptoms(0-24 months post radiotherapy)
- Patient reported outcomes- health status(0-24 months post radiotherapy)
- Clinician reported acute toxicity(0-6 months post radiotherapy)
- Loco-regional MIBC control(0-5 years post radiotherapy)
- Overall survival(0-5 years post radiotherapy)
- Progression free survival(0-5 years post radiotherapy)
- Patient reported outcomes- sexual function(0-24 months post radiotherapy)