A randomised adjuvant Phase III Trial of six cycles of docetaxel and hormonal treatment versus hormonal treatment in patients with intermediate or high-risk prostate cancer treated with radical radiotherapy. AdRad” - AdRad

ICORG, All-Ireland Cooperative Oncology Research Group0 个研究点目标入组 924 人开始时间: 2006年10月16日最近更新: 2014年2月3日

研究概览

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•Inclusion Criteria
•> 18 and =75 years of age.
•Radical radiotherapy for prostate cancer.
•WHO/ECOG performance status 0 – 1.
•Histological proven adenocarcinoma of the prostate within 9 months prior to randomisation.
•One of the following:
•-T2 with Gleason score (4+3) and PSA >10 ng/ml.
•-T2 with Gleason score of 8-10, and any PSA.
•-Any T3 tumour.
•Prior neoadjuvant hormone therapy is mandatory for all patients
•Adequate haematological-, liver- and kidney function:
•(Haemoglobin greater than or equal to 110 g/l,
•neutrophils greater than or equal to 1.5 x 10 to the power of 9/ l,
•platelets greater than or equal to 150 x 10 to the power of 9/ l,
•ASAT and ALAT less than or equal to 1.5 x UNL,
•ALP < 1.5 x UNL,
•bil less than or equal to UNL,
•creatinine less than or equal to 1.5 x UNL)
•Written informed consent.
•- ALAT and ASAT less than or equal to 2.5 x UNL, Alk. Phos < 6 x UNL. In the presence of extensive bone disease, Alk. Phos is > 6 x UNL, the patient should be eligible in the study.
•(c) Renal function :
•-Creatinine < or equal to 1.5 x UNL (ie NCI grade < 1)
•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

•M+ (Positive bone scan indicating spread of tumour or visceral metastases).
•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 for other cancer.
•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.
•Symptomatic peripheral neuropathy = CTCAE grade 2.
•Patients who by altered physical or psychological state are not able to co-operate or participate in the trial.

发起方

ICORG, All-Ireland Cooperative Oncology Research Group