Selective Use of Postoperative Radiotherapy AftEr MastectOmy

A phase III randomised trial to assess the role of adjuvant chest wall irradiation in ‘intermediate risk’ operable breast cancer following mastectomy

Trial objectives:

To determine the effect of ipsilateral chest wall irradiation following mastectomy and axillary clearance for women with operable breast cancer at ‘intermediate risk’ of loco-regional recurrence on the primary endpoint of overall survival.

Chief Investigator: Dr Ian Kunkler

Weston General Hospital

Email: iankunkler @ yahoo.com

Trial co-ordinator: Julian Lipscombe

ISDESG-ISD Epidemiology & Stats Group

NHS National Services Scotland

Email: jlipscombe @ nhs.net

Tel: 013 1275 7137

Fax: 013 1275 7500

QA contact: Karen Venables

National Trials QA Team

Mount Vernon Cancer Centre

Email: karen.venables @ nhs.net

Tel: 01923 844714

Fax: 01923 844138

(NB to use email addresses please remove space before and after @ )

QA PROGRAMME

In the Supremo trial, the quality assurance programme will allow us to confirm that participants have understood the technical guidelines within the protocol and implemented them correctly and that the dose prescription is delivered with appropriate documentation.

The QA programme we are using will build on that developed for the START trial, which has provided a basis for consensus among radiotherapy centres in the UK.

Pre-trial QA requirements:

QA introduction

Questionnaires

• National radiotherapy trials QA baseline questionnaire (UK centres only)
• Radiotherapy trials QA staff questionnaire
• Trial specific questionnaire – sets out precise details of the technique to be used, together with specimen patient outlines to be used to produce ideal plans.

Planning exercise

Patients A and B must be planned according to the trial protocol and returned electronically or via CD to the RTTQA centre for analysis.

• Instructions for planning exercise
• Patient A CT scan
• Patient A manual outline
• Patient B CT scan
• Patient B manual outline
• Notes for manual outlines

QA checklist - please ensure all components have been completed

Ongoing QA requirements:

• Plans, including verification images, for the first 5 patients
• 1 in every 10 plans thereafter
• TLD - 1 in 10 patients (identified at randomisation)
• Cardiac study - full CT data set will be required for patients randomised to this study

The data from the quality assurance programme will be analysed separately from the main trial. You will be notified of any major discrepancies.