Isotoxic IMRT Study
Research type
Research Study
Full title
Isotoxic Intensity Modulated Radiotherapy (IMRT) in stage III non small cell lung cancer (NSCLC) - A Feasibility Study.
IRAS ID
111613
Contact name
Corinne Faivre-Finn
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Clinicaltrials.gov Identifier
Research summary
Background
Around 12,000 patients are diagnosed with stage III NSCLC in the UK each year and their survival is approximately 15% at 5 years. The majority of patients are not suitable for the gold standard treatment,concurrent chemo-radiotherapy (chemotherapy and radiotherapy deliverd at the same time), so novel strategies integrating technological advances in radiotherapy (RT) need to be evaluated. There is evidence that improving local control in lung cancer leads to increased survival. Strategies to improve local control in stage III NSCLC include escalating and individualising the RT doses, which are limited by the dose delivered to surrounding tissue. We hypothesise that this will be facilitated by the use of a novel RT technique called intensity modulated radiotherapy (IMRT).
Aims
To demonstrate the feasibility of delivering isotoxic RT using IMRT and twice-daily RT in patients who are not suitable for concurrent chemo-radiotherapy (CTRT).
Methods
Patients with stage III NSCLC, who are not suitable for concurrent CTRT, will be treated with individualised doses of radiation. Radiotherapy will be delivered twice-daily over a maximum period of 4.5 weeks using IMRT and the dose of radiation will be increased until one or more of the organs at risk tolerance or the maximum dose is reached.
35 patients will be recruited in this prospective multicentre feasibility study. Stopping rules are in place to ensure the safety of patients. If this treatment regimen proves feasible it will then be incorporated into a planned national randomised phase II study incorporating 3 other novel RT regimens that are currently under assessment in the UK. This is part of a national strategy endorsed by the NCRI Lung Clincial Studies Group. Furthermore the QA programme for this study will allow the standardisation of lung IMRT in the UK by providing a framework for the implementation of this technique.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0480
Date of REC Opinion
8 Aug 2013
REC opinion
Further Information Favourable Opinion