NCT01219790已完成1 期
STUDY OF PHASE ID'ACIDE ZOLEDRONIC ASSOCIATED WITH A STRONG DOSE Hypofractionated Radiotherapy in Bone Metastases Vertebral Prostate Adenocarcinoma
Institut Cancerologie de l'Ouest3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Neurological toxicity was defined as NCI-CTC grade V4.de greater than 2.
研究概览
简要总结
This study will determine the delayed neurotoxicity (12 months) of a hypofractionated high dose irradiation (3 Gy x 9) associated with zoledronic acid.
The administration of zoledronic acid repeat dosages defined under the Authorisation on the Market.
All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at least 48 hours apart each, for a treatment to J1, J3 and J5.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the prostate metastatic Age> 18 years
- •Life expectancy> 12 months;
- •Performance Index status <3 PSA ≥ 4 ng / ml Zoledronic acid treatment in progress as recommended by the Authority for the Marketing Creatinine clearance above 30 ml / min Lack of maintenance causing disabling pain not lying down long (30 minutes) No history of radiotherapy to the region to be irradiated Absence of neurological signs compression Distance between the metastasis and spinal cord ≥ 5 mm Absence of metastases unstable metastatic epidural spinal cord compression or may require surgery before radiotherapy
排除标准
- •Concomitant treatment with a drug testing, participation in another clinical trial within <30 days
- •Presence of central system nervous desease (symptoms or progressive), Patient with a severe neurological disease, current manifestations of peripheral neuropathy> grade 2 NCI-CTC V4 Existence of another severe pulmonary disease, liver or kidney, digestive likely to be exacerbated by treatment,
- •Untreated with zoledronic acid
- •Treatment with a bisphosphonate other than Zoledronic acid
- •Clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or to any excipients in the formulation of Zometa.
- •Creatinine clearance below 30 ml / min
- •History of another primary cancer (except basal cell skin cancer)
- •Or demented patient with altered mental status who can not obtain informed consent. / Persons deprived of liberty or under guardianship
- •Pain not resulting in maintaining the prolonged supine position (30 minutes)
- •PSA below 4 ng / ml
- •History of radiotherapy in localized tumor site
- •Distance between the metastasis and spinal cord <5 mm
- •Monitoring impossible because of psychological, sociological or because of geographical distance.
研究组 & 干预措施
irradiation + zometa
Experimental
干预措施: external radiotherapy (Radiation)
irradiation + zometa
Experimental
干预措施: Acide zoledronic (Drug)
结局指标
主要结局
Neurological toxicity was defined as NCI-CTC grade V4.de greater than 2.
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (3)
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