A study to determine the feasibility and acceptability of conducting a phase III randomised controlled trial comparing stereotactic Ablative Radiotherapy (SABR) with surgery in patients with peripheral stage I non-small cell lung cancer (NSCLC) considered Higher risk of complications from surgical resection.

eeds Teaching Hospitals NHS Trust0 个研究点目标入组 24 人开始时间: 2015年2月4日最近更新: 2022年6月13日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 24

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2016 Protocol article in http://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0046-2 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32616595/ (added 17/05/2022)

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Main study:
•1. Histological and/or clinical and radiological diagnosis of NSCLC
•2. Primary tumour characteristics:
•2.1. Peripherally located tumour as defined in the RTOG 0236 study and UK SABR Consortium guidelines. This states that the tumour must be more than 2cm in axial diameter from a major airway = No Fly Zone”. This includes the trachea, carina, right and left main bronchus and extends to the bifurcation of the right upper, right middle, right lower, left upper and left lower lobe bronchioles (See diagram below).
•2.2. Maximal axial diameter = 5 cm measured on lung windows on computed tomography.
•3. No evidence of hilar or mediastinal lymph nodes involvement. Any hilar or mediastinal lymph nodes that are either PET positive or >1cm in axial dimension must be sampled by mediastinoscopy, endo-bronchial ultrasound or oesophageal endoscopic ultrasound and demonstrate negative cytology and/or pathology.
•4. Local lung cancer MDT consensus opinion that patient is considered suitable for either surgical resection or SABR treatment and also to be at higher risk of complications from surgical resection.
•5. Age = 18
•6. Female patients must satisfy the investigator that they are either not of childbearing potential or not pregnant (i.e. be willing to undergo a pregnancy test within 72hrs of surgery or day 1 of SABR treatment),.
•7. Able and willing to provide written informed consent.
•Qualitative sub-study:
•1. Approached to consider entry into the SABRTooth trial
•2. Decided against participation in the SABRTooth trial/ dropped out after randomisation but before treatment
•3. Willing and able to comply with requirements of this study protocol
•4. Written informed consent obtained to participate in this study

排除标准

•Main study:
•1. Previous radiotherapy within the planned treatment volume
•2. History of clinically significant diffuse interstitial lung disease
•3. Any history of concurrent or previous invasive malignancy that in the opinion of the investigator could impact on trial outcomes
•4. Clinical or radiological evidence of metastatic spread
•5. History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
•6. Previous systemic therapies, including targeted and experimental treatments, for their current lung cancer diagnosis.
•Qualitative sub¬study:
•1. Decline participation in this study
•2. Unable to comply with requirements of this study protocol

研究者

发起方

eeds Teaching Hospitals NHS Trust

相似试验

已完成

不适用

Feasibility and efficacy of resistance training in cerebral palsy (CP)

ISRCTN90378161Brunel University (UK)64

已完成

不适用

CanWalk: a walking intervention for people with recurrent or metastatic cancerRecurrent or metastatic cancerCancer

ISRCTN42072606King's College London (UK)60

已完成

不适用

The development of an asthma-tailored pulmonary rehabilitation programme for individuals with severe asthmaAsthma

ISRCTN96143888niversity Hospitals of Leicester NHS Trust (UK)273

已完成

不适用

A pilot study to investigate the feasibility and acceptability of a cognitive behavioural suicide prevention therapy for people in acute psychiatric wards.Topic: Mental HealthSubtopic: Suicide and self-harmDisease: Suicide and self harmMental and Behavioural Disorders

ISRCTN17890126Manchester Mental Health & Social Care Trust (UK)51

已完成

不适用

Pilot study for the evaluation of a combined psycho- and physiotherapeutic treatment program for patients with chronic pelvic pain syndrome (CPPS)

ISRCTN43221600niversity Medical Center Hamburg60