TARGIT Trial  

Information for investigators

Trial Summary

TARGIT is an international randomised clinical trial designed to test the hypothesis that the strategy of delivering a single dose of targeted intraoperative radiotherapy (IORT) in patients eligible for breast conserving therapy (with the addition of whole breast radiotherapy in those patients at high risk of recurrence elsewhere in the breast [e.g. lobular carcinomas and extensive intraductal component]) is equivalent to a conventional course of post-operative external beam radiotherapy (EBRT). The primary endpoints are local and loco-regional recurrence rates. It is a pragmatic trial in which each participating centre has the option to define more restrictive entry criteria than in the core protocol. Only centres with access to the Intrabeam may enter patients into the trial. For further information about Intrabeam click here Eligible patients are those with tumours of good prognosis suitable for breast conserving surgery. After giving consent patients are randomised to either IORT or to EBRT. They may receive any other adjuvant treatments as deemed necessary, except for neoadjuvant therapy. The protocol requires that patients be followed at six monthly intervals for five years and then annually.


How do I join the TARGIT trial?

To join the trial sites must have the Intrabeam machine and at least 40 patients per year who are eligible for TARGIT.

The next steps to gain membership are:

• Obtain ethical approval



• Complete 5 pilot boost cases which should be audited by an experienced clinician or Carl Zeiss clinical specialist



• Complete a Treatment Policy Document provided by the TARGIT team, which comprises of a series of questions which outline the way you intend to treat TARGIT patients at your site e.g. minimum patient age



• Receive International Steering Committee (ISC) approval for your Treatment Policy Document



• Begin randomising patients

If you wish to learn more about the trial, you may register to access further information and also receive trial updates if desired.



Disclaimer: The purpose of most clinical trials is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, modifications to dose or schedule may be required for participants if they develop side effects from the treatment or test. The therapy described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. An investigator associated with this clinical trial should be consulted before using this protocol.