GenOMICC Study: Genetics of mortality in Critical Care (Covid & non-Covid patients)

Exceeded site target recruitment of 4. As of 22/10/2021 our recruitment is 98. This has been led by Lily Zitter (non-medic PI)

UK-ROX STUDY: Evaluating the clinical and cost-effectiveness of a conservative approach to oxygen therapy for invasively ventilated adults in intensive care.

RD&E are the third top recruiters in the country with 72 patients.

RECOVERY STUDY: Randomised evaluation of Covid-19 therapy.

First participant recruited to the DMF arm of the study.

NOVAVAX Study: A Phase 3, Randomised, Observer-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom

Final study visits for Novavax are happening from November 8th through to Xmas.

PASHiOn trial. Phase 1 was a single site, non-randomised, pre-trial technology check and safety assessment of the new Tailored Osteotomy Knee Alignment (TOKA).

TOKA is a customised 3D metal printed plate with a customised jig which hopes to reduce the likelihood of soft tissue irritation, reduce surgery time and increase surgery accuracy when compared to Tomofix; the most widely used device for HTO procedures in the UK. The TOKA device has been through extensive pre-clinical testing but this is the first time it has been used in patients. Phase 2 will be opening after a safety analysis and will be a multi-centred RCT comparing Personalised against Standard High tibial Osteotomy.

The Bellever Team have recruited the first 5 patients to Phase 1 study.

UPDATE to Oncology Radiotherapy Studies

Fran Hood is the research radiographer working with the Oncology Research Team. We can see the direct and real-time impact that their studies have made for our patients especially during the pandemic.

PATHOS Trial: Post-operative adjuvant treatment for HPV-positive tumours (HPV +ve oropharyngeal cancer)

Has reduced the burden of treatment aiming to preserve swallow) RD&E are in the top 6 recruiters in UK!

PACE-C Study: International randomised study of prostatectomy vs stereotactic body radiotherapy (SBRT) and conventional radiotherapy vs SBRT for organ-confined prostate cancer. (Localised prostate cancer)

This study continues to recruit well. Half of participants have only had to come for 5 treatments instead of 20 (significant for anyone, but especially if you have to travel from North Devon).

This study is also supporting the increase and development of SABR treatments within the department, a technique that delivers fewer treatments of larger doses of radiation to a tightly defined volume.

Pivotal Boost Study: A phase III randomised controlled trial of prostate and pelvis

versus prostate alone radiotherapy with or without prostate boost.

In the midst of the pandemic being open for trial also allowed us to reduce prostate with pelvic nodes treatments from 37 to 20.

The Fast Forward Study: Randomised clinical trial testing a 1-week course of curative whole breast radiotherapy against a standard 3-week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer.

Long-since closed to recruitment but this study paved the way during Covid times for reducing the number of treatments from 15 to 5 for many breast cancer patients, and this is now our clinical standard treatment for this group of patients.

HUGE CONGRATULATIONS to your contributions to patient care Oncology Research Team

LUNG MATRIX STUDY: Multi-drug, genetic marker-directed, non-comparative, multi-centre, multi-arm phase II trial in non-small cell lung cancer

The Stratified Medicine Programme 2 (SMP2) study closed to recruitment at end of Aug 2021. SMP2 is primarily a screening programme for the National LungMatrix Trial (NLMT) and at the RDE we successfully screening 64 Non-small cell lung cancer patients. Of these, 8 patients went on to have genetic marker-directed treatments within the National LungMatrix Trial (NLMT).

From the SMP2 Team at Cancer Research UK Clinical Trials Unit, University of Birmingham

We are proud to have set-up one of the first genomic testing platforms in the UK and are excited to see what the future holds for precision medicine in NSCLC patients. SMP2 has been transformative of the UK screening and trial landscape. We will ensure the results and lessons learnt through SMP2 are shared with the research community, patients and public in due course.