CTRI/2018/05/014054招募中3 期
Randomised controlled trial of Prostate Radiotherapy In high risk & node positive disease comparing Moderate & Extreme hypofractionation.
Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre2 个研究点 分布在 1 个国家目标入组 464 人开始时间: 2018年5月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 464
- 试验地点
- 2
- 主要终点
- 1.To assess the 4 year Biochemical Failure free Survival (BFFS) between the two arms..
研究概览
简要总结
The aim of the study is to compare the efficacy with SBRT and moderate hypo-fractionation in high risk and node positive prostate cancer.
Study Design and Randomization.
Patients will be randomized to one of the below mentioned arms using stratified block randomization method.
Arm 1 (Standard arm): Moderate hypo-fractionated RT 66-68 Gy/25#
Arm 2 (Test arm): Extreme hypo-fractionated RT with SBRT 35-37.5 Gy/5#
Stratification :
Stratification will be done for the following parameters.
-
Nodal status: N0 Vs N+
-
Medical castration vs Surgical castration
3.Centre: TMC Mumbai Vs TMC Kolkata
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Participants must be histologically proven, adenocarcinoma prostate 2.Localised to the prostate or pelvic lymph nodes 3.High risk prostate cancer as per NCCN definition clinical stage T3a or Gleason score 8/Gleason grade group4 or Gleason score 9-10/gleason grade group 5, PSA > 20 ng/mL.orVery high risk prostate cancer i.e T3b-T4 or Primary Gleason pattern 5/Gleason grade group 5 or > 4cores Gleason score8-10/Gleason grade group 4 or5 4.Ability to receive long term hormone therapy/ orchidectomy 5.KPS >70 6.No prior history of therapeutic irradiation to pelvis 7.Patient willing and reliable for follow-up and QOL 8.Signed study specific consent form.
排除标准
- •1.Evidence of distant metastasis at anytime since presentation.
- •Life expectancy<2 year.
- •Previous RT to prostate or prostatectomy.
- •A previous trans-urethral resection of the Prostate(TURP).
- •Severe urinary symptoms or with severe IPSS score (>15) inspite of being on hormonal therapy for 6months which in the opinion of the physician precludes RT.
- •Patients with known obstructive symptoms with stricture.
- •Any containdication to radiotherapy like inflammatory bowel disease.
- •Uncontrolled co-morbidities including, but not limited to diabetes or hypertension.
结局指标
主要结局
1.To assess the 4 year Biochemical Failure free Survival (BFFS) between the two arms..
时间窗: Four years
次要结局
- 1.To evaluate acute and late toxicity with both treatments.(2.To find the Prostate cancer specific survival and overall survival of patients receiving moderately hypofractionated RT and SBRT.)
研究者
研究点 (2)
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