Update on Head and Neck Cancer Research Studies in the West of England
Recent research updates on head and neck cancer studies in the West of England, including recruitment data, status of various clinical trials, and upcoming studies like PETNECK.2 and HoT. Insights into site openings, closures, and sample sizes provide a comprehensive overview of the current research landscape in the region.
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SWAG Network Head and Neck Cancer Clinical Advisory Group Research Update - Claire Matthews 23/11/2021
National Recruitment to Head and Neck Cancer Studies Apr 2020 - Nov 2021 Data cut 17/11/2021 Source: ODP All Portfolio
National vs Regional Recruitment to Head and Neck Cancer Studies Apr 2020 - Nov 2021 National Recruitment Apr 2020 - Mar 2021 Apr 2021 - Nov 2022 Apr 20 - Mar 21 recruitment during the pandemic Apr 21 - Nov 22 Small recovery of recruitment to research West of England Recruitment Apr 2020 - Mar 2021 Apr 2021 - Nov 2022 Apr 20 - Mar 21 recruitment during the pandemic Apr 21 - Nov 22 Recovery of recruitment to research not being seen yet Data cut 17/11/2021 Source: ODP All Portfolio
West of England (+ Taunt/Yeov) Head and Neck Cancer Studies 21/22 CPMS No. Short Name Status Sites Open Closure England Recruits Sample Size England 18621 CompARE Trial Open UHBW - BHOC (24/35), GHFT - Chelt (3/3), SFT - Musgrove (11/6), RUH (0/3) New site 06/07/2015 31/01/2022 Study extension in progress 670 413 18645 PATHOS Open UHBW - BHOC (16/18), RUH (11/6) 02/10/2015 01/11/2022 740 562 37926 Best-Of Open UHBW (1/6) 01/01/2018 01/01/2026 12 3 Cemiplimab with/without ISA101b in HPV16Positive Platin-Resistant OPC 39082 Open SFT - Musgrove (1/4) 16/05/2019 31/03/2022 7 17 40113 POPPY Open SFT - Musgrove (4/3) 05/07/2019 31/07/2022 53 24 42229 INOVATE Open RUH (19/10) 01/01/2020 24/05/2022 166 137 Ph 3 Pembrolizumab+/-Lenvatinib First Line treatment in R/M HNSCC 43466 Open SFT - Musgrove (0/4) 05/08/2020 31/01/2022 21 9 43839 TORPEdO Open UHBW - BHOC (4/4), RUH (1/5) New site 24/02/2020 20/07/2023 160 53 44709 MK7902-009 Ph2 Open SFT - Musgrove (1/4) 18/12/2020 21/11/2023 14 6 45262 PETNECK 2 - qualitative study Closed to Rec., No Follow Up UHBW - BRI (4/6) 11/11/2020 30/06/2021 515 84 47618 VOLUME-PRO Closed to Rec., In Follow Up GHFT - Chelt (1/1), SFT - Musgrove (1/4) 02/03/2021 30/07/2021 34 20
West of England In Setup Head and Neck Cancer Studies 21/22 CPMS No. Short Name Sites Planned Opening Planned Closure Sample Size England Sample Size UK 50360 PETNECK 2 - Feasibility Study and RCT, Version 1.0, 10-May-2021 Yeovil District Hospital NHS Foundation Trust 01/12/2021 30/07/2025 653 758 48988 HoT - Hemithyroidectomy or Total- Thyroidectomy in 'low-risk' thyroid cancers Somerset NHS Foundation Trust 01/08/2021 Hope to open study in Oct 31/07/2025 344 456 47863 PD-1/TIM-3 & PD-1/LAG-3 vs. Nivolumab In Patients With Advanced And/Or Metastatic Esophageal Cancer University Hospitals Bristol And Weston Nhs Foundation Trust 15/11/2021 30/06/2022 - 30
National In Setup Head and Neck Cancer Studies 21/22 CPMS No. Short Name Title Phase Planned Opening Planned Closure Sample Size England 49918 SafeRDC What can we learn about diagnostic safety culture in cancer referral pathways, which will inform future improvement and service design of diagnostic pathways across the NHS? N/A 01/09/21 30/09/23 110 45364 Lymphatic mapping Of Oropharyngeal Cancer Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients with Oropharyngeal Cancer II 01/04/20 01/10/24 120 39187 OBERON - Cetuximab immunotherapy combination in head and neck cancer Phase I/Ib trial of durvalumab (MEDI4736), tremelimumab + cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck - OBERON I/Ib 01/06/20 08/04/21 22
CRN High Level Objectives (HLOs) 21/22 Efficient Study Delivery metrics (study level): Proportion of new commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed CRN sites (studies opened and closed within the year) [80%] TG4050.02 Clinical Trial. No sites in WE, closest site Southampton Proportion of commercial contract studies in the MR process achieving or surpassing their recruitment target during their planned recruitment period [80%] No H&N studies included Proportion of non-commercial studies in the MR process achieving or surpassing their recruitment target during their planned recruitment period [70%] HARE-40 - no sites in WE, closest site Southampton
Managed Recovery Studies CPMS Study ID Short Name Title Open Closure Sample Size England England Recruits 44836 Open-label Phase II Trial with High Risk NMIBC and FGFR Alterations - 42756493BLC2003_THO R2 A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Gu rin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions 19/04/21 10/08/22 7 2 30900 HARE-40 Therapeutic HPV vaccine trial +/- anti-CD40 in HPV-driven squamous cell carcinoma. 11/04/17 31/03/22 44 24 43839 TORPEdO A phase III trial of intensity-modulated proton beam therapy versus intensity modulated radiotherapy for multi-toxicity reduction in oropharyngeal cancer 24/02/20 20/07/23 160 53
CRN High Level Objectives (HLOs) 21/22 Participant Experience: Number of NIHR CRN Portfolio study participants responding to the Participant Research Experience Survey (PRES) each year [1,155]. 928 surveys returned to date (3/11/21) Aim for each trust is to return surveys from 5% of participants recruited. Overall figure is 3.9% (range across the trusts is 0.8% - 34.1%) Ensure study is identified on completed PRES forms
NIHR ODP Open data platform. Data on performance and restart across whole CRN, including all specialty areas NIHR Be Part of Research See which studies are open across the country National Cancer Research Institute Portfolio Maps View current national portfolio of open, closed and in set up cancer studies Find a Clinical Research Study (ODP) Search for a study to fit criteria. Good for horizon scanning, eligibility criteria
Research Delivery Manager claire.matthews@nihr.ac.uk Research Portfolio Facilitator iqra.hussain@nihr.ac.uk Sub-specialty Lead steve.thomas@bristol.ac.uk
