A randomised phase III trial of highly conformal hypofractionated image guided (“Stereotactic”) radiotherapy (HypoRT) versus conventionally fractionated radiotherapy (ConRT) for inoperable early stage I non small cell lung cancer.

The purpose of this study is to investigate whether radiotherapy given as three large doses over a period of two weeks (hypofractionated radiotherapy) is more effective than standard radiotherapy for patients with non-small cell lung cancer that has not spread beyond the lung. Although surgery is the most effective treatment for early lung cancer, many patients are not fit enough for an operation. The alternative treatment to surgery is standard radiotherapy which is normally ‘fractionated’ that is, given as a number of small doses over a period of weeks. Experience has shown that many small treatments are safer than using a few large doses (hypofractionation) because there is less risk of damage to normal tissues. Recent advances in technology have however resulted in greater accuracy and with it a reduction in the amount of normal tissue affected by the radiation, so the risks of hypofractionation damaging normal tissue are of less concern. Initial results obtained with hypofractionated radiotherapy for early stage non-small cell lung cancer indicate that it may be more effective in controlling the cancer. However, it has never been compared directly with standard fractionation in a randomised trial, so this study aims to determine if hypofractionation is more effective, results in longer life expectancy and if it is just as safe as standard fractionation.

Primary Sponsor

Trans-Tasman Radiation Oncology Group (TROG)

Participating Centres

Final Accrual

101

Current Accrual

Trial Chairperson

Prof David Ball, Peter MacCallum Cancer Centre, VIC

Clinical Trial Registration

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