NCT00653848Unknown3 期
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
Scandinavian Prostate Cancer Group1 个研究点 分布在 1 个国家目标入组 378 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- PSA progression rate
研究概览
简要总结
As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour burden it should be effective in primarily treated intermediate and high risk prostate cancer as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be tested in a randomised phase III trial where patients will be randomized either to docetaxel or surveillance
详细描述
Primary endpoint:
- PSA progression rate, ASTRO guidelines.
Secondary endpoints:
- PSA doubling time after progression
- Quality of Life (QoL)
- Safety
- Metastases free survival
- Overall survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men > 18 and ≤75 years of age.
- •WHO/ECOG performance status 0 -
- •Histological proven adenocarcinoma of the prostate within 12 months prior to randomisation
- •One of the following:
- •T2 with Gleason score 7(4+3 ) and PSA >10 ng/ml to < 70 ng/ml
- •T2 with Gleason 8-10, any PSA < 70 ng/ml
- •any T3 tumour
- •Prior neoadjuvant hormone therapy is mandatory for all patients
- •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)
- •Written informed consent
排除标准
- •N+ clinical or pathological
- •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 radiotherapy to the pelvic region.
- •Previous chemotherapy within 5 years.
- •Systemic corticosteroids within 6 months prior to randomisation.
- •Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation.
- •Active untreated infectious disease, including tuberculosis, MRSA.
- •Active gastric ulcer.
- •Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel)
- •Other serious illness or medical condition
研究组 & 干预措施
Docetaxel arm
Experimental
six of docetaxel every third week + hormonal treatment
干预措施: docetaxel (Drug)
结局指标
主要结局
PSA progression rate
时间窗: From randomization to progression
According to RTOG-ASTRO guidelines
次要结局
- PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival(From randomisation to year 2014)
研究者
研究点 (1)
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