The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study: A Phase II Study of Chemo - Hormonal Therapy and Radiation in High Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To investigate if the inversion of sequencing of multi - phase, intensity - modulated radiotherapy (IMRT), for the treatment of patients with high - risk prostate cancer, can improve the delivery of concurrent, weekly Docetaxel chemotherapy, in conc
研究概览
简要总结
The purpose of this study is to see if sequence inversion of Intensity - modulated Radiotherapy (IMRT) for prostate cancer, can improve the safety and deliverability of concurrent docetaxel chemotherapy with long - term hormonal therapy. The hypothesis is that inverting the traditional sequence of radiotherapy can delay the time to treatment - induced bowel toxicity.
详细描述
1.0 Objectives
1.1 Primary objective
To investigate if the inversion of sequencing of multi - phase, intensity - modulated radiotherapy (IMRT), for the treatment of patients with high - risk prostate cancer, can improve the delivery of concurrent, weekly Docetaxel chemotherapy, in concert with long - term androgen deprivation (LTAD).
1.2 Secondary objective
To investigate if the inversion of sequencing of multi - phase IMRT can improve the time to grade 2 or 3 gastrointestinal toxicity, the total amount of Docetaxel that can be delivered, or the quality of life in patients receiving concurrent, weekly Docetaxel chemotherapy, in concert with long - term androgen deprivation (LTAD).
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
- Double (Participant, Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A histological diagnosis of adenocarcinoma of the prostate
- •Life expectancy greater than 5 years.
- •ECOG performance status <
- •Signed, written informed consent prior to randomization.
- •Any one, or more, of the following criteria:
- •TNM stage T2c, T3a or T3b
- •Gleason score 8 to 10, as determined by central institutional review.
- •PSA > 20 mcg/L, but < 50 mcg/L. OR Have a > 50% chance of recurrence after radical prostatectomy, as predicted by the Kattan Nomogram and
- •Post - op PSA < 1.0 mcg/L.
- •Must be able to start protocol treatment within 6 months from date of surgery.
- •No evidence of metastasis, as determined by bone scan and Chest x-ray/CT abdomen/pelvis.
- •Adequate marrow reserve and end - organ function
- •Leukocytes > 3,000/mcL.
- •Absolute neutrophil count > 1,500/mcL
- •Platelets > 100,000/mcL
- •Total bilirubin < 1.2 x upper limit of normal for the institution.
- •AST(SGOT)/ALT(SGPT) greater than 1.5 X institutional upper limit of normal
- •Creatinine within normal institutional limits OR
- •Creatinine clearance > 60 mL/min using the Crockfort - Gault formula for patients with creatinine levels above institutional normal.
排除标准
- •PSA > 50 µg/L.
- •Previous pelvic radiotherapy
- •Sensitivity to Docetaxel chemotherapy.
- •Grade 2 or greater NCI CTCAE version 3.0 neuropathy.
- •Prior malignancy within the last 5 years, other than prostate cancer, except:
- •Patients with adequately treated non - melanoma cutaneous malignancies.
- •Patients with a history of a curatively treated malignancy (including patients with superficial bladder cancer) who have not had evidence of recurrence for a minimum of 5 years.
- •Patients with a history of hypersensitivity to polysorbate
- •Patients with a known history of viral hepatitis (B,C).
研究组 & 干预措施
Standard Radiotherapy Sequence Arm
Standard sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) first, then prostate/prostate bed last
干预措施: Docetaxel (Drug)
Standard Radiotherapy Sequence Arm
Standard sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) first, then prostate/prostate bed last
干预措施: Leuprolide Acetate (Eligard®) (Drug)
Standard Radiotherapy Sequence Arm
Standard sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) first, then prostate/prostate bed last
干预措施: Intensity-Modulated Radiotherapy (Radiation)
Experimental Radiotherapy Sequence Arm
Experimental sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) last, prostate/prostate bed first
干预措施: Docetaxel (Drug)
Experimental Radiotherapy Sequence Arm
Experimental sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) last, prostate/prostate bed first
干预措施: Leuprolide Acetate (Eligard®) (Drug)
Experimental Radiotherapy Sequence Arm
Experimental sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) last, prostate/prostate bed first
干预措施: Intensity-Modulated Radiotherapy (Radiation)
结局指标
主要结局
To investigate if the inversion of sequencing of multi - phase, intensity - modulated radiotherapy (IMRT), for the treatment of patients with high - risk prostate cancer, can improve the delivery of concurrent, weekly Docetaxel chemotherapy, in conc
时间窗: 3 years
次要结局
- To investigate if the inversion of sequencing of multi - phase IMRT can improve the time to grade 2 or 3 gastrointestinal toxicity.(3 years)
- total amount of Docetaxel that can be delivered(3 years)
- quality of life in patients receiving concurrent, weekly Docetaxel chemotherapy, in concert with long - term androgen deprivation (LTAD).(3 years)
研究者
Derek R Wilke MD,MSc,FRCPC
Research Director, Department of Radiation Oncology
Queen Elizabeth II Health Sciences Centre