SABR CtE v2.0

• Research type

  Research Study

• Full title

  Commissioning Through Evaluation:Stereotactic Body Radiotherapy

• IRAS ID

  207942

• Contact name

  Anastasia Chalkidou

• Contact email

  anastasia.chalkidou@kcl.ac.uk

• Sponsor organisation

  Kings College London

• Duration of Study in the UK

  4 years, 4 months, 11 days

• Research summary

  Stereotactic Ablative Radiotherapy (SABR), is an emerging novel radiation technology. SABR is a specialised radiotherapy treatment planning technique resulting in a high dose to the target with steep dose gradients resulting in rapid dose fall off outside the target area. This results in high biologically effective dose (BED) while minimising the dose received by the normal tissues, and could potentially minimise the radiotherapy treatment toxicity and side effects.

  The technique requires specialist positioning equipment and/or imaging (stereotaxis) to confirm correct targeting (accuracy) and it can be delivered using either standard linear accelerators or specially designed devices which are dedicated to delivering stereotactic treatments. Using a small number of fractions provides the opportunity for cost savings compared with conventional fractionation or surgical alternatives, and may free up capacity within NHS radiotherapy departments.

  There is now evidence from multiple non-randomised retrospective studies demonstrating that SABR is associated with local control rates of ~90% and can be given with minimal toxicity. Some early findings suggest it may be possible to delay the need for systemic therapy and improve progression-free survival using SABR. Further data is required to determine whether these benefits translate into an overall survival benefit.

  The current SABR indications for which evidence is rapidly accumulating are:

  •oligometastatic cancer (3 or fewer sites of metastatic disease)
  •cancer that has recurred in a site treated previously treated with radiotherapy (re-irradiation)
  •patients with hepatocellular carcinoma

  These 3 groups of patients should receive SABR within this Commissioning through Evaluation (CtE) proposal, which will serve to improve access to SABR within the UK and enable data collection to further expand the current evidence base. It is possible that additional indications will be added to the program in due course, including benign spinal conditions and renal cancer.

  AS part of this CtE project the centres delivering SABR treatment will be collecting routine clinical data and data on quality of life, pain symptoms and patient experience using the interim access tool developed by KiTEC. A research database application where these data will be stored in the long term will be done separately at a later stage. KiTEC will be undertaking the analysis of this data in order to answer the NHS England evaluation question whether the treatment offers to these patients improved clinical outcomes n combination with less side effects and improved quality of life.

• REC name

  North East - York Research Ethics Committee

• REC reference

  16/NE/0285

• Date of REC Opinion

  23 Aug 2016

• REC opinion

  Favourable Opinion