EUCTR2006-001657-94-SE进行中（未招募）不适用
Randomized adjuvant phase III trial of six cycles of docetaxel+hormonal treatment versus hormonal treatment in patients with intermediate or high-risk prostate cancer treated with radical radiotherapy.AdRad”Scandinavian Prostate Cancer Group Trial 13 - AdRad
Scandinavian prostate cancer group0 个研究点目标入组 378 人开始时间: 2006年11月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 378
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. > 18 and =75 years of age
- •2. Radical radiotherapy for prostate cancer
- •3. WHO/ECOG performance status 0 – 1
- •4. Histologically proven adenocarcinoma of the prostate within 9 months prior to randomisation.
- •5. One of the following:
- •T2 with Gleason 7 (4+3) and PSA >10 ng/ml to T2 with Gleason 8-10, PSA any T3 tumours.
- •6. Prior neoadjuvant hormone therapy is mandatory for all patients
- •7. Adequate haematological-, liver- and kidney function (less than 1.5 x UNL for creatinine, less than 1.5 X UNL for liver laboratory values except bil < UNL).
- •8.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •2. N+ clinical or pathological
- •3. Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past five years.
- •4. Previous radiotherapy to pelvic region.
- •5. Previous chemotherapy within five years.
- •6. Systemic corticosteroids within 6 months prior to randomisation.
- •7. Unstable cardiovascular disease within 6 months prior to randomisation.
- •8. Active untreated infectious disease.
- •9. Active gastric ulcer.
- •10. Known hypersensitivity to Polysorbate 80.
- •11. Other serious illness or medical condition.
- •12. Symptomatic peripheral neuropathy = CTCAE grade 2.
- •13. Patients who by altered physical or psychological state not are able to co-operate or participate in the study.
研究者
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