1. We have broadened the radiology eligibility criteria so that all (CT-staged) T3 tumours are eligible.
Patients with any T3 tumours are now eligible for entry into FOxTROT. This will mean inclusion of ‘intermediate’ risk patients, defined as depth of extramural invasion between 1-≤5mm, as well as ‘high’ risk patients with ≥5mm invasion.
2. We have introduced an option for a shorter (12 week) total chemotherapy duration known as ‘FOxTROT lite’.
This could be attractive for older patients (eg over 70 years) for whom 6 months of combination chemotherapy is considered excessive. This will be a decision made by the oncologist, on an individual patient basis, offering chemotherapy for 3 months (i.e. 6 weeks of pre-operative and 6 weeks of post-operative or 12 weeks post-operative), rather than 6 months, provided that this decision is stated at the time of randomisation.
3. We have introduced a capecitabine option for patients not on panitumumab.
Following a safety data review capecitabine can now be used for those FOxTROT patients who are not randomised to receive panitumumab (i.e. either KRAS-mutant, KRAS-status undetermined or the patient declines the panitumumab randomisation). For these patients, oncologists can select either the OxCap or OxMdG regimen. If patients enter the panitumumab randomisation they must be given OxMdG.
Email: FOxTROT-trial@contacts.bham.ac.uk
Tel: 0121 415 9105
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To randomise a patient please log into:
https://www.trials.bham.ac.uk/FOxTROT
If you do not have log in details please contact the FOxTROT office who will be able to set these up for you.
