ACTRN12614000341628进行中（未招募）未知
Randomised controlled trial (RCT) of chemotherapy patients at risk of cardiotoxicity undergoing cardioprotection guided by measurement of LV strain compared with cardioprotection guided by measurement of left ventricular (LV) ejection fraction for avoidance of cardiotoxicity
Menzies Research Institute Tasmania0 个研究点目标入组 331 人开始时间: 2014年3月31日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 331
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
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •i. Patients actively undergoing chemotherapy at increased risk of cardiotoxicity;
- •use of anthracycline WITH current (but not necessarily concurrent)
- •trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR
- •tyrosine kinase inhibitors (eg sunitinib) OR
- •cumulative anthracycline dose >450g/m2 of doxorubicin, or equivalent other anthracycline cumulative dose (eg for epirubicine >900g/m2).OR
- •increased risk of HF (any two of age >65y, type 2 diabetes mellitus, hypertension, previous cardiac injury eg. myocardial infarction)
- •ii. Live within a geographically accessible area for follow-up
- •iii. Are able and willing to provide written informed consent to participate in the study (this includes the ability to communicate fluently with the investigator and that the patient is mentally competent)
排除标准
- •- Unable to provide written informed consent to participate in this study
- •- Participating in another clinical research trial where randomized treatment would be unacceptable
- •- Valvular stenosis or regurgitation of >moderate severity
- •- History of previous heart failure (baseline NYHA >2)
- •- Systolic BP <110mmHg
- •- Pulse <60/minute
- •- Inability to acquire interpretable images (identified from baseline echo)
- •- Contraindications/Intolerance to beta blockers or ACE inhibitors
- •- Existing therapy with both beta blockers and ACE inhibitors
- •- Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
研究者
相似试验
进行中（未招募）
1 期
Clinical trial with chemotherapy for patients with non-resectable locally advanced pancreatic cancer and addition of chemo-radiotherapy for patients with borderline resectable pancreatic cancer. DPSG - ”Danish Pancreatic cancer Study Group”EUCTR2011-000703-40-DKOdense University Hospital53
已完成
不适用
Randomized clinical trial of adjuvant chemotherapy for cancerbreast with recurrence Loco regional Recessed Radically chemo therapy vs. observatio-C50 Malignant neoplasm of breastMalignant neoplasm of breastC50PER-079-03INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG,
进行中（未招募）
不适用
A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck - NDMetastatic and/or Recurrent Squamous Cell Carcinoma of the Head and NeckMedDRA version: 6.1Level: HLTClassification code 10024530EUCTR2006-003786-13-ITAMGEN S.P.A.650
进行中（未招募）
1 期
A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and NeckMetastatic and/or Recurrent Squamous Cell Carcinoma of the Head and NeckMedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2006-003786-13-FRAmgen Inc650
进行中（未招募）
不适用
A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and NeckMetastatic and/or Recurrent Squamous Cell Carcinoma of the Head and NeckMedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2006-003786-13-HUAmgen Inc650