NL-OMON44779已完成3 期
Randomized Phase 3 Study On The Assessment Of Late Toxicity By Comparing IMRT High Dose External Beam Radiotherapy Only With External Beam Radiotherapy Combined With HDR Or PDR Brachytherapy In Patients With Intermediate/high Risk Prostate Cancer - Late Toxicity of radiotherapy in prostate cancer patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •T1c-T2a with Gleason * 6 and PSA 15-60 ng/ml, N0/x, M0
- •prostate carcinoma
- •T1c-T2a with Gleason 7 and PSA 10-50 ng/ml, N0/x, M0
- •T1c-T2c with Gleason 8 and PSA * 20ng/ml, N0/x, M0
- •T2b-T3a with Gleason * 7 and PSA * 40ng/ml, N0/x, M0
- •* Accessible for brachytherapy
- •* WHO performance status * 2
- •* International Prostate Symptom Score (IPSS) * 20 (appendix F)
- •* Maximal urinary flow * 10 ml/sec
- •* Post voiding residual bladder volume * 200 ml
- •* Written informed consent
排除标准
- •* Other malignancy (except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been cured for at least 5 years)
- •* Metallic hip prothesis
- •* Inflammatory bowel diseases such as colitis ulcerosa or M. Crohn in medical history
- •* Prior radiotherapy on prostate or pelvic area
- •* Co-morbidity preventing general or spinal anaesthesia
- •* Very high risk patients ( PSA>60, G >8, T-stadium >T3a) beyond the above mentioned group.
- •* T1-3, N+,M+
研究者
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