A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 198
- 试验地点
- 3
- 主要终点
- Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
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 phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.
详细描述
OBJECTIVES:
- To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer.
- To determine the optimal dose level of this treatment regimen to be used in future studies.
OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume < 450 cc vs high small bowel volume ≥ 450 cc).
Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of prostate cancer meeting 1 of the following criteria:
- •Stage T3b/T4 disease or radiological or pathological pelvic nodal metastases
- •Localized disease (stage pT2-T4) with > 30% estimated risk of pelvic nodal metastases
- •High-risk (Gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease according to the National Collaborative Cancer Network (NCCN)
- •Has undergone prostatectomy AND has stage T2-T3a, N0 disease with extensive high-risk disease (Gleason score ≥ 8) or seminal vesicle or lymph node involvement
- •Candidate for radical radiotherapy
- •PATIENT CHARACTERISTICS:
- •No inflammatory bowel disease or other small bowel disease
- •PRIOR CONCURRENT THERAPY:
- •No prior pelvic radiotherapy or surgery (excluding prostatectomy)
排除标准
- 未提供
结局指标
主要结局
Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
次要结局
- Overall survival
- Local control
- PSA control
- Acute side effects as assessed weekly by the RTOG scoring system
- Quality of life
- Patterns of recurrence