NCT01039038终止2 期
A Phase II Study Evaluating the Feasibility of a Dose Increase by a Boost of Curietherapy in PDR Associated With the Extern Radiotherapy in Intermediate Risk in the Prostate Cancer
Centre Francois Baclesse2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of patients with a delivered dose by a boost of curietherapy is at least 40 Gy (D95) associated to a dose of 34 Gy for extern radiotherapy
研究概览
简要总结
The objective of the trial is to evaluating the feasibility of dose increase by a boost of curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in intermediate risk in prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years and ≤ 75 years
- •Life expectancy >10 years
- •Localized prostatic adenocarcinoma and histologically proven
- •Intermediate risk cancer(T2b or PSA between 10 and 20 or Gleason = 7(3+4) according to Amico criteria
- •Metastasis or pelvic pathologic ganglion (≥ 10 mm) absence
- •No previous treatment by radiotherapy and/or curietherapy
- •Hormonotherapy authorized before and during the study
- •Rectal or uretero-vesical pathology
- •Signed informed consent
- •Social security system affiliation
- •Individual deprived of liberty or placed under the authority of a tutor.
- •No anesthesia contraindication
排除标准
- •Adenocarcinoma not histologically proven
- •Metastases presence
- •Pathological nodes presence(≥ 10 mm)
- •Prior prostate endoscopic resection
- •history of other malignancy except for appropriately treated superficial basal cell skin cancer
- •Medical contraindications to anesthesia
- •Patients with uncontrolled psychiatric disease or medical disease incompatible with the protocol
- •Impossibility to respect the medical follow-up of the protocol for geographical, social or psychic reasons
结局指标
主要结局
Proportion of patients with a delivered dose by a boost of curietherapy is at least 40 Gy (D95) associated to a dose of 34 Gy for extern radiotherapy
时间窗: at 5 months
次要结局
- Acute toxicities at month 3 after end of treatment: late toxicities, survival without biological relapse, without local relapse or metastatic evolution, feasibility of MRI use in prostatic CTV(at 5 months)
研究者
研究点 (2)
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