NCT00201916已完成3 期
A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
Ontario Clinical Oncology Group (OCOG)31 个研究点 分布在 1 个国家目标入组 936 人开始时间: 1995年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 936
- 试验地点
- 31
- 主要终点
- time to PSA failure
研究概览
简要总结
To improve the management of patients with early stage prostate cancer.
详细描述
To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung
- •stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification
排除标准
- •PSA > 40 mcg/L
- •previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer
- •prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
- •simulated volume exceeds 1000 cm3
- •previous pelvic radiotherapy
- •inflammatory bowel disease
- •serious non-malignant disease which would preclude radiotherapy or surgical biopsy
- •geographic inaccessibility for follow-up
- •psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol
- •unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy
- •failure to give informed consent to participate in the study
结局指标
主要结局
time to PSA failure
时间窗: 10 years
次要结局
- toxicity(10 years)
- quality of life(6 years)
- economic(10 years)
- positive biopsy at two years post radiation(see above)
- disease free survival(10 years)
研究者
研究点 (31)
Loading locations...
相似试验
撤回
2 期
Trimodality Approach of Low Dose iOnizing Radiation With or Without Neoadjuvant Pembrolizumab and Prostatectomy for Men With Intermediate/High Risk Prostate Cancer (TALON)Prostate CancerNCT04569461Duke University30
已完成
1 期
Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate CancerProstate CancerNCT00129025Alberta Health services35
进行中（未招募）
不适用
Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant LesionAdenocarcinoma of ProstateNCT01913717European Institute of Oncology65
进行中（未招募）
不适用
Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate CancerProstate CancerNCT01794403University of Miami161
招募中
2 期
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate CancerProstate CancerNCT06397703NYU Langone Health392