Radiation therapy has been used for many years as an effective form of treatment against many cancer types, yet it remains less well researched and utilised than other well-known cancer therapies such as chemotherapy. Lucy McParland at PHASTAR focuses on some of these challenges faced in general across all clinical trials involving radiotherapy, followed by a closer look at the different trial phases.

Extract:

‘Considerations for Clinical Trial Design Involving Radiotherapy’

Radiation therapy has been used for many years as an effective form of treatment against many cancer types; yet it remains less well researched and utilised than other well-known cancer therapies such as chemotherapy. Radiotherapy works to shrink or completely eradicate cancer cells with the aim of reducing the risk of recurrence or to cure the cancer completely. When used in this setting, the intent is known as “radical” or “curative” treatment. Radiotherapy can also be given in the palliative setting when a cure is not possible to relieve symptoms caused by the cancer.

Radiotherapy can be used alone or in combination with other treatments such a chemotherapy, which is known as chemo[1]radiation. It is also often given prior to (neoadjuvant) or post (adjuvant) surgery. It is a very versatile treatment coming with its own nuances compared to other commonly used cancer therapies such as chemotherapy, surgery, and immunotherapy.

The amount or dose of radiotherapy delivered is measured in grays (Gy) per fraction. For example, a patient treated with 62Gy in 28 fractions would receive 2.2Gy of radiotherapy per fraction/ administration. Typically, patients would receive one fraction per day, Monday to Friday.

These differences need to be well understood when it comes to designing and conducting clinical trials of radiotherapies, meaning trials for radiotherapy, can require unique strategies and methodologies, and can often present challenges not faced in other settings.

This article will focus on some of these challenges faced in general across all clinical trials involving radiotherapy, followed by a closer look at the different trial phases.

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