Total Neoadjuvant Treatment in Oesophageal Adenocarcinoma: The TNT-OAC trial feasibility study

  • Research type

    Research Study

  • Full title

    Multi-centre, three-arm Phase II/III feasibility, randomised control trial to compare total neoadjuvant treatment (TNT) to standard of care perioperative chemotherapy in patients with newly diagnosed oesophageal adenocarcinoma (OAC) eligible for surgery.

  • IRAS ID

    1012559

  • Contact name

    Russell Petty

  • Contact email

    r.petty@dundee.ac.uk

  • Sponsor organisation

    University of Dundee/NHS Tayside

  • ISRCTN Number

    ISRCTN51679511

  • Research summary

    Oesophageal adenocarcinoma (OAC) is a type of cancer found in the food pipe (oesophagus). Despite improvements in treatments, more half of people diagnosed with OAC don't survive more than 5 years after diagnosis (although this improves when diagnosed early and if the patient is younger and fit). Currently, if OAC is thought to be 'potentially curative' at diagnosis, patients will undergo chemotherapy (termed ‘FLOT’) or chemoradiotherapy (mixture of chemo- and radiotherapy, termed ‘CROSS’) to shrink the tumour before it is surgically removed.
    With FLOT, patients undergo four cycles of chemotherapy before surgery and four more cycles after. Patients undergoing CROSS receive a mixture of chemotherapy with radiotherapy before surgery and sometimes immunotherapy to help the immune system to fight any remaining cancer.
    Completing either of these provides the best chance at living cancer-free after surgery, however, this can be challenging and less than half of people undergoing chemotherapy after surgery complete all four cycles.
    Pressures during the COVID-19 pandemic meant that some people with OAC had all their chemotherapy before surgery (termed ‘total neoadjuvant treatment’ or ‘TNT’), and many of these individuals are living cancer-free more than 5 years on. We want to find out if this method of delivering FLOT (FLOT-TNT) or some FLOT (four cycles) with CROSS (FLOT-CROSS) offers patients with OAC a better chance of completing treatment compared with current FLOT regimens.
    To do this, we will be recruiting individuals with newly diagnosed ‘potentially curable’ OAC to our trial and randomly (by chance) allocating them to one of the three treatment arms (FLOT-TNT, FLOT-CROSS or standard FLOT). We will compare how well they tolerate their treatment and how they progress through surgery and beyond. Results of this study will help us determine whether a larger trial should be carried out to see which of these treatment options should become standard of care for OAC.

  • REC name

    Wales REC 5

  • REC reference

    26/WA/0082

  • Date of REC Opinion

    13 May 2026

  • REC opinion

    Further Information Favourable Opinion