Accelerating the Development and implementation of Personalised Treatments of DNA Damage Response agents and radiotherapy +/- immunotherapy for head and neck squamous cell cancer
Trial summary:
This open-label, multi-centre, platform trial will evaluate the safety and efficacy of different DNA Damage Repair (DDR) agents, or different immunotherapy agents and/or DDR and immunotherapy combinations, together with radiotherapy in patients with head and neck squamous cell carcinoma (HNSCC) being treated curatively. The trial protocol will allow for the evaluation of new DDR agents and for roll-on to a randomised phase II/III trial. The initial component of this trial protocol will open with a single-arm dose-finding phase Ib/IIa trial. Arm 1 – Phase Ib/IIa study of AZD6738) will take approximately 54 months to recruit and assess for safety assessment. Up to 60 patients will be given AZD6738 and up to 20 patients (Control Group) will be followed-up on standard of care treatment (radiotherapy alone).
RT QA summary:
All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.
| QA Process | QA Activity | Required for Trial | Additional Details |
|---|---|---|---|
| Pre-Accrual | Facility Questionnaire |  | |
| Outlining Benchmark Case | | 1 case | |
| Planning Benchmark Case | | 1 case | |
| Dummy Run | |||
| During Accrual | Individual Case Review | | Prospective: first larynx and hypopharynx cases |
| Data collection | | All patients | |
| Dosimetry | | ||
| QA Streamlining | | CompARE, TORPEdO |
RTTQA contact: adeptqa.enh-tr@nhs.net
Chief investigator: Professor Hisham Mehanna
RT Lead: Dr Andrew Hartley, Dr Charles Fong, Dr Anthony Fong
Sponsor: University of Birmingham ADEPT-DDR@trials.bham.ac.uk
Funder: AstraZeneca