The aim of InterAACT is to compare two different chemotherapy regimens for the treatment of inoperable locally advanced or metastatic anal cancer to demonstrate which is more effective and less toxic for patients with this disease.

Anal cancer is a rare cancer, with approximately 150 cases being diagnosed in Australia every year. However, the number of anal cancer cases has been steadily growing and has doubled in the last 20 years.  InterAACT is an international, multicentre, open label, randomised, phase II trial that aims to establish which chemotherapy regime is more active in patients with inoperable locally advanced or metastatic anal cancer. This is the first time that a formal comparison of two chemotherapy regimens has been performed.  The results have the potential to establish a new standard of care for this group of patients.


Trial Summary:

This randomised phase II trial will evaluate activity and toxicity of two different chemotherapy regimens for the first line treatment of patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anus (SCCA). The main aim of the study is to set a standard of care for this relatively uncommon disease and inform feasibility and design of future multicentre, international phase III trials.

The exploratory translational substudy aims to provide important information on the biology of SCCA and identify tumour biomarker with a potential prognostic or predictive role.

Supported By:

Royal Marsden Hospital; AGITG; NHMRC CTC


Adult patients with inoperable, locally recurrent or metastatic disease.

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Activation Date:



Amitesh Roy