EUCTR2006-002772-17-BE进行中（未招募）1 期
Immediate or early salvage post-operative externalradiotherapy combined with concomitant and adjuvanthormonal treatment versus immediate or early salvage postoperative external radiotherapy alone in pT3a-b R0-1 cN0M0 / pT2R1 cN0M0, Gleason score 5-10 prostatic carcinoma. A Phase III study
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 600 人开始时间: 2009年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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
- •- Patients with clinical stage cT1-2-3aN0M0 prostate cancer clinically assessed after a preoperative work-up including physical examination, chest X-ray, bone scan, CT scan or MRI of the entire pelvis and abdomen.
- •- Pre-operative PSA = 30ng/ml
- •- Presenting after radical prostatectomy (all techniques allowed:retropubic, laparoscopic or perineal) with:
- •*Gleason sum 5-10
- •*Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans-section higher than 2 mm) or pT3a-b (irrespective of margin status)
- •*Negative lymph node (LN) status (pN0) by LN sampling or LN dissection or cN0 (by MRI) pNx. *Post-operative PSA undetectable (PSA is below the detection level of the laboratory) within 3 months of surgery
- •- Age = 80 years.
- •- WHO performance status 0-1.
- •- Normal organ functions as shown by all of the following (measured within 2 weeks prior to randomization):
- •*hemoglobin = 110 g/l
- •*WBC =3 x 109/l
- •*platelet count = 100 x 109/l
- •- Medically fit to receive radiation therapy. Preferably the patient should be fully continent at randomization.
- •- Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Patients can be randomized in this trial only once.
- •- To enter the trial in the immediate post-operative setting
- •* External irradiation must be planned to start within 26 weeks after surgery. Randomization should ideally take place within 22 to maximum 25 weeks after surgery
- •and minimum 1 week before the start of the post-operative treatment and the PSA should be undetectable or very low (< 0.2 ng/ml) within 2 weeks before
- •randomization.
- •- To enter the trial in the early salvage setting
- •* biochemical failure defined by rising PSA documented
- •* Either by 3 PSA measurements (nadir and 2 consecutive increases measured at least 2 weeks apart) with final PSA value > 0.1 ng/ml and = 0.5 ng/ml;
- •* Or, in the case where the 3rd value is not > 0.1 ng/ml, by 4 PSA measurements (nadir and 3 consecutive increases measured at least 2 weeks apart).
- •* Final measurement should be within 2 weeks before randomization and = 0.5 ng/ml. Salvage treatment must be planned to start within 2 months after biochemical
- •failure. Randomization should take place minimum 1 week before starting the salvage treatment.
- •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
- •- prior pelvic irradiation.
- •- prior bilateral orchiectomy.
- •- prior chemotherapy within the 5 years prior to randomization.
- •- prior hormonal treatment except neo-adjuvant treatment lasting = 3 months.
- •- other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years.
- •- psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial.
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