NCT01045226终止不适用
A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.
详细描述
Detailed Description
PRIMARY OBJECTIVES:
I. Feasibility of proton radiation therapy (RT) using standard fractionation.
SECONDARY OBJECTIVES:
I. To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free survival) with standard fractionation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate adenocarcinoma within 365 days of registration
- •Clinical stages T1a-T2a N0 M0
- •For any pelvic lymph node >= 1.5cm, biopsy of the lymph node is mandatory
- •Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-6; > 6 cores is strongly recommended; the highest Gleason score in any core reported on the pathology report will be used for determining inclusion
- •PSA values < 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy.
- •Alkaline phosphatase within 60 days prior to registration. If alkaline phosphatase is elevated > 2 x the upper limit of institutional normal (UNL), patient must have radiological correlation to assess for metastases
- •Zubrod status 0-1 documented within 60 days of registration
- •Prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy
- •Patients must give IRB-approved study-specific informed consent
- •Patients must complete all required tests listed within the specified time frames
- •Patients must be able to start treatment within 56 days of registration
- •Members of all races and ethnic groups are eligible for this trial
排除标准
- •Clinical stages T2c or greater
- •PSA of 10 ng/ml or greater
- •Gleason score 7 or higher
- •Evidence of distant metastasis
- •Evidence of lymph node involvement
- •Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery
- •Previous pelvic radiation for prostate cancer
- •Androgen deprivation therapy prior to radiation is allowed; however, it is not acceptable if continued during radiation or as adjuvant therapy
- •Active rectal diverticulitis, Crohn's disease, or ulcerative colitis are not allowed
- •Prior systemic chemotherapy for prostate cancer
- •History of proximal urethral stricture requiring dilatation
结局指标
主要结局
As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
时间窗: 5 years
Acute toxicity as assessed by NCI CTC Version 3.0
时间窗: 90 days
次要结局
- Biochemical/clinical progression-free survival(Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive)
- Late toxicity as assessed by RTOG/EORTC late morbidity scoring system(90 days)
研究者
研究点 (2)
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