The SABRTooth feasibility trial protocol: 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 withReportar como inadecuado




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Pilot and Feasibility Studies

, 2:5

First Online: 01 February 2016Received: 21 October 2015Accepted: 18 January 2016DOI: 10.1186-s40814-016-0046-2

Cite this article as: Snee, M.P., McParland, L., Collinson, F. et al. Pilot Feasibility Stud 2016 2: 5. doi:10.1186-s40814-016-0046-2

Abstract

BackgroundStage I non-small cell lung cancer NSCLC is potentially curable, and surgery is considered to be the standard of care for patients with good performance status and minimal co-morbidity. However, a significant proportion of patients with stage I NSCLC have a poorer performance status and significant medical co-morbidity that make them at higher risk of morbidity and mortality from surgery.

Stereotactic ablative radiotherapy SABR, which uses modern radiotherapeutic techniques to deliver large doses of radiation, has shown superiority over conventional radiotherapy in terms of local control and toxicity and is a standard of care for patients with stage I NSCLC who are at too high risk for surgery. However, it is not known whether surgery or SABR is the most effective in patients with stage I NSCLC who are suitable for surgery but are less fit and at higher risk surgical complications. Previous randomised studies have failed to recruit in this setting, and therefore, a feasibility study is required to see whether a full randomised control trial would be possible.

Methods-designSABRTooth is a UK-based, multi-centre, open-label, two-group individually 1:1 randomised controlled feasibility study in patients with peripheral stage I NSCLC considered to be at higher risk from surgical resection. The study will assess the feasibility of conducting a definitive large-scale phase III trial. The primary objective is to assess recruitment rates to provide evidence that, when scaled up, recruitment to a large phase III trial would be possible; the target recruitment being 54 patients in total, over a 21-month period. There are multiple secondary and exploratory objectives designed to explore the optimum recruitment and data collection strategies to help optimise the design of a future phase III trial.

DiscussionTo know whether SABR is a better, equivalent or inferior alternative to surgery for higher risk patients is a key question in lung cancer. Other studies comparing SABR to surgery have closed early due to poor recruitment, and therefore, the SABRTooth feasibility study has been designed around the UK National Health Service NHS cancer pathway incorporating many design features in order to maximise recruitment for a future definitive phase III trial.

Trial registrationcontrolled-trials.com ISRCTN13029788

KeywordsNSCLC Lung cancer SABR Surgery Radiotherapy Feasibility Randomised Stereotactic AbbreviationsBEDbiologically equivalent dose

CTcomputerised tomography

CTRUClinical Trials Research Unit

CPEXcardio-pulmonary exercise testing

ECGelectrocardiogram

ECOG PSEastern Cooperative Oncology Group performance status

EORTCEuropean Organization for Research and Treatment of Cancer

EQ-5D™Euro-Quality of Life 5D utility score

EQ-VAS™Euro-Quality of Life visual analogue scale

GCPGood Clinical Practice

ISWTIncremental Shuttle Walk Test

ITTintention-to-treat

MDTmultidisciplinary team

NCDRNational Cancer Data Repository

NLCANational Lung Cancer Audit

NHSNational Health Service

NInon-inferiority

NIHRNational Institute for Health Research

NSCLCnon-small cell lung cancer

PETpositron emission tomography

QALYquality-adjusted life year

QLQ-C30Cancer Quality of Life Questionnaire

QLQ-LC30Lung Cancer-Specific Quality of Life Questionnaire

QoLquality of life

OSoverall survival

RCTrandomised controlled trial

SABRstereotactic ablative radiotherapy

SCserious complication

SOPstandard operating procedure

TMGtrial management group

TSCtrial steering committee

USCunexpected serious complication

An erratum to this article can be found at http:-dx.doi.org-10.1186-s40814-016-0095-6.

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Autor: M. P. Snee - L. McParland - F. Collinson - C. M. Lowe - A. Striha - D. R. Baldwin - B. Naidu - D. Sebag-Montefiore - W.

Fuente: https://link.springer.com/







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