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The FOxTROT Trial: Progress Update

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The FOxTROT Trial: Progress Update

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    1. The FOxTROT Trial: Progress Update NCRI Colorectal Cancer Clinical Studies Group – Surgical Trials Meeting Manchester 2010

    2. Age distribution of FOxTROT patients

    3. Recruitment Update 59 open centres Further 23 to open soon Patients randomised from 39 sites

    4. Participating Centres

    5. Recruitment by Centre

    6. FOxTROT Recruitment

    8. FOxTROT Forms - Return Rates

    9. DMEC Deadline FOxTROT DMEC meeting taking place 29th June 2010 Database closed for analysis end of May Please return your forms!

    10. Pathology Samples 75 patients represented that we have blocks and slides complete for 63 with absolutely everything75 patients represented that we have blocks and slides complete for 63 with absolutely everything

    11. Amendments to FOxTROT trial design Introduction of version 5.0 FOxTROT protocol Widening of radiological eligibility criteria Introduction of OxCap for those patients not receiving p-mab Introduction of “FOxTROT lite” BCTU submitting to MREC and MHRA Local approvals – either R&D or local coordinator Letters to PIs, oncologists, surgeons, radiologist, pathologist, nurses Hard copies of protocol to key site staff All staff fully informed before changes implemented at site

    12. FOxTROT Website

    13. What we have learnt from sites: Whole team involvement is key! Entire MDT on board Radiologist needs to “think FOxTROT”, need to id patients after CT & before MDT Inform ward staff & theatre staff of study Do not give patients date for surgery prior to 1st oncology appointment Presentations to MDT prior to study opening, once local approval in place, once patient pathway set up

    14. Role of FOxTROT study team How we can help Assistance with setting up patient pathway Presenting study to your MDT Organisation of radiology workshops Laminated posters Provision of laminated reminder cards for surgeons diaries Biopsy blocks for KRAS testing

    15. Coloproctology Team at BCTU

    16. Key – Whole MDT must think FOxTROT STRATEGY: Problem - Original leaflet given out by CNS said that surgery is 1st treatment after diagnosis Leaflet now changed to mention FOxTROT Laminated cards for endoscopy suites & front of surgeon’s diaries Ward staff and theatre staff also made aware of FOxTROT AIM: Radiologists to id patients after CT & prior to MDT Email to oncologists & nurses to inform Book appointment to see oncologist (Trial info should come form oncologist) Book dates for PICC and chemotherapy DIFFICULTIES Patients given date for surgery early

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