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 ProcessQA ActivityRequired for TrialAdditional Details
Pre-AccrualFacility Questionnaire
Outlining Benchmark Case1 case
Planning Benchmark Case1 case
Dummy Run
During AccrualIndividual Case ReviewProspective: first larynx and hypopharynx cases
Data collectionAll patients
QA StreamliningCompARE, TORPEdO

RTTQA contact:

Chief investigator:  Professor Hisham Mehanna

RT Lead: Dr Andrew Hartley, Dr Charles Fong, Dr Anthony Fong

Sponsor: University of Birmingham

Funder: AstraZeneca