ACTRN12610000479000进行中（未招募）3 期
Trans Tasman Radiation Oncology Group (TROG) 09.02 - A randomised phase III trial comparing time to local failure between highly conformal hypofractionated image guided (stereotactic) radiotherapy (HypoRT) versus conventionally fractionated radiotherapy for inoperable early stage I non small cell lung cancer
Trans Tasman Radiation Oncology Group (TROG)0 个研究点目标入组 100 人开始时间: 2010年6月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients may be included in the trial only if they meet all of the following criteria:
- •· Histologically or cytologically confirmed non-small cell lung cancer diagnosed within 6 weeks prior to randomisation. The following primary cancer types are eligible:
- •squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar
- •cell carcinoma, large cell neuroendocrine, and non-small cell carcinoma not otherwise
- •· Aged 18 years or older
- •· Disease stage T1N0 or T2aN0 (International Union against Cancer (UICC Tumour, Nodes, Metastases (TNM) stage, 7th Ed, 2009), based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) performed within 4 weeks prior to randomisation. T stage should be based on tumour size alone (i.e. no atelectasis).
- •· An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •· The tumour has a peripheral location, defined as at least 1 cm beyond the
- •mediastinum and 2 cm beyond the bifurcation of the lobar bronchi.
- •Tumour is assessed as inoperable either i) because of unfitness for surgery as
- •determined by the lung multidisciplinary team including thoracic surgeons and
- •respiratory physicians or ii) because the patient refuses surgery.
- •· Female patients of childbearing potential and male patients must agree to use
- •adequate contraception throughout the treatment phase of the study.
- •· If female and of childbearing potential, a negative pregnancy test was performed within 7 days prior to randomisation.
- •· Patient is expected to survive and be available for follow up for two years.
- •· Patient has provided written informed consent for participation in this trial prior to any protocol-specified procedures.
- •· Patient undergoing chemoradiation has satisfactory haematological and biochemical
- •parameters as described below:
- •Absolute Neutrophil count (ANC) greater than or equal to 1.5 x 109, Platelets greater than or equal to 100 x 109/L, Hemoglobin (Hb) greater than or equal to 100g/L, creatinine clearance greater than or equal to
- •40mls/min (patients with calculated creatinine clearance greater than or equal to 40mls/min and < 60mls/min must have this confirmed by nuclear medicine Glomerular Filtartion Rate (GFR) scan), bilirubin <1.5 x Upper Limit of Normal (ULN) and Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST)< 2x
排除标准
- •Patients who fulfil any of the following criteria are not eligible for admission to the trial:
- •· Centrally located tumours (< 1.0 cm from mediastinum or < 2.0 cm from bifurcation of
- •lobar bronchus).
- •· Tumours within 1.0 cm of the chest wall.
- •· Prior chemotherapy.
- •· Previous radiotherapy to the area to be treated.
- •· Women who are pregnant or lactating.
- •· Patient with multiple synchronous primary tumours requiring radiotherapy.
研究者
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