ACTRN12615000223538已完成2 期
A Phase 2 Multicentre Clinical Trial Exploring the Safety and Feasibility of a Stereotactic Radiotherapy Boost to the Prostate with Fractionated External Beam Radiotherapy in Men with Prostate Cancer
Dr Mark Sidhom0 个研究点目标入组 129 人开始时间: 2015年3月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1. Patient capable of giving informed consent
- •2. Histological diagnosis of prostate cancer (PC)
- •3. Intermediate or High risk disease respectively defined by any one of:
- •a.Baseline PSA 10-20, Gleason grade 7 disease, Clinical stage T2b-c OR
- •b.Baseline PSA greater than or equal to 20, Gleason grade 8-10 disease, Clinical stage T3
- •4. For high risk patients, negative conventional staging in the form of a:
- •a. PSMA PET scan OR
- •b. T99m whole body bone scan AND
- •b. Either CT of the abdomen and pelvis or MRI pelvis
- •5. No previous pelvic radiotherapy
排除标准
- •1. ECOG performance status >1
- •2. Hip prosthesis
- •3. Inability to have intraprostatic fiducials inserted.
- •4. Inability to have a MRI due to:
- •a. Implanted magnetic metal eg intraocular metal
- •b. Pacemaker / Implantable defibrillator
- •c. Extreme claustrophobia
- •5. Clinical stage T4 (tumour invasion into adjacent anatomical structures)
- •6. Inflammatory bowel disease
- •7. Severe obstructive urinary symptoms
- •8. Inability to meet planning objectives
研究者
相似试验
招募中
2 期
A Multi-center Phase II Clinical Trial to Investigate the Safety and Efficacy of Preoperative Short-Term Radiotherapy and Chemotherapy for Locally Advanced Rectal CancerJPRN-jRCTs051220171Matsuda Takeru25
进行中（未招募）
不适用
A multicenter phase II clinical trial assessing the efficacy of the combination of lapatinib and capecitabine in patients with non pretreated brain metastasis from HER2 positive breast cancer. - LANDSCAPEEUCTR2008-001084-10-FRFNCLCC
进行中（未招募）
2 期
A prospective, multicenter phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients with relapsed/refractory transformed aggressive LymphomaC83.3Diffuse large B-cell lymphomaDRKS00023793niversitätsmedizin der Johannes Gutenberg-Universität Mainz26
进行中（未招募）
1 期
A phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients aggressive Lymphoma.Malignant B-cell lymphomaMedDRA version: 21.0Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002373-59-DEniversity Medical Center of the Johannes Gutenberg University Mainz64
未知
2 期
A Phase II, Multicenter, Clinical Trial to Evaluate The Efficacy and Safety of Bevacizumab in Recurrent Malignant GliomaMalignant gliomaJPRN-jRCT2080220811Chugai Pharmaceutical Co., Ltd.31