TheFOxTROT protocol v6.0 (09/07/2012) has now been approved.
We are currently in the process of notifying the R&D department of the sites involved with the trial. Please contact the FOxTROT office if you are unsure whether your site has received all the latest documentation. The changes to the protocol were as follows:
1. Removal of Arm D; post-operative chemotherapy plus panitumumab.
Following the publication of results from a recent study (the Intergroup NO147 trial) post-operative panitumumab was withdrawn from FOxTROT, i.e. Arm D of the trial was removed. As you will be aware, this change was implemented in summer 2011 as an urgent safety measure with immediate effect. The new version of the FOXTROT protocol, v6.0; 9th July 2012, fully details this change.
2. Updating of clinical trial evidence on EGFR-directed monoclonal antibody therapies.
3. Clarifications of trial eligibility criteria.
This includes clarification that patients with high-grade dysplasia on histology plus unequivocal radiological evidence of cancer are eligible for the trial.
4. Removal of the interval CT scan.
The CT scan after neoadjuvant chemotherapy, prior to surgery is now no longer required.
5. New versions of the Patient Information Sheet, consent form and GP letter.
The PIS and consent form have been updated to reflect the removal of post-operative panitumumab. The current version of these two documents is version 4.0. The GP letter has also been updated and is now version 3.0.