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

未提供0 个研究点目标入组 924 人开始时间: 2006年10月4日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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
•T2 with Gleason 8-10, any 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

•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.

发起方

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