EUCTR2005-002355-40-IS
进行中（未招募）
1 期
An open randomized phase III trial of six cycles of docetaxel versus surveillance after radical prostatectomy in prostate cancer patients with high grade pT3 or margin positive pT2 - AdPro
Scandinavian prostate cancer group0 个研究点目标入组 400 人2006年10月30日
相关药物Taxotere
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Scandinavian prostate cancer group
- 入组人数
- 400
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Men \> 18 and \=70 years of age.
- •WHO/ECOG performance status 0 – 1\.
- •Histological proven adenocarcinoma of the prostate.
- •One of the following:
- •opT2 with Gleason score 4\+3 or 8–10 and positive margins in the radical prostatectomy specimen or
- •oany pT3a tumour with Gleason score 4\+3 or higher or
- •opT3b tumour with any Gleason score 7 or higher
- •If pre\-operative PSA ? 10\.0 ng/ml, lymph node dissection should be performed.
- •Post\-operative PSA \< 0\.5 ng/ml.
- •Adequate haematological\-, liver\- and kidney function. (Hemoglobin \> 110 g/l, neutrophils \> 1\.5 x 109/ l, platelets \> 150 x 109/ l, ASAT and ALAT \< 1\.5 x ULN, ALP \< 1\.5 x ULN, creatinine \< 1\.5 x ULN, total serum bilirubin \= 1 x ULN)
排除标准
- •\*M\+ (Positive bone scan indicating spread of tumour).
- •\*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.
- •\*Previous hormonal manipulation (e.g. LHRH analogues and/or antiandrogens) affecting prostate cancer cells.
- •\*Previous radiotherapy to pelvic region.
- •\*Previous chemotherapy.
- •\*Systemic corticosteroids within 6 months prior to randomisation.
- •\*Unstable cardiovascular disease within 6 months prior to randomisation.
- •\*Active untreated infectious disease.
- •\*Active gastric ulcer.
- •\*Known hypersensitivity to Polysorbate 80\.
结局指标
主要结局
未指定
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