PHASE 1B/II TRIAL OF CHECKPOINT INHIBITOR (PEMBROLIZUMAB AN ANTI PD-1 ANTIBODY) PLUS STANDARD IMRT IN HPV INDUCED STAGE III SQUAMOUS CELL CARCINOMA (SCC) OF ANUS (CORINTH)
Trial summary:
The CORINTH trial is for patients with more advanced (stage IIIA/B) anal cancer. The numbers of patients with anal cancer is increasing and only 65% patients with this later stage anal cancer have not had a recurrence 3 years after treatment. Anal cancer responds well to chemoradiotherapy (CRT) and this would be the treatment usually chosen for clinical care. There is still significant room for improvement, especially for those with more advanced cancer at the time of diagnosis. The chemotherapy will be the same as given for standard of care (Mitomycin and 5FU or capecitabine) and the radiotherapy (RT) will be delivered using a technique where the dose (intensity) of radiotheorapy (RT) can be modulated for different areas of the tumour (Intensity Modulated RT – IMRT).
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 |  | Including Process Document |
| Outlining Benchmark Case | | 1 case | |
| Planning Benchmark Case | | 1 case | |
| Dummy Run | |||
| During Accrual | Individual Case Review | | |
| Data collection | | Brief clinical history, diagnostic imaging, full planning data including; CT images, structure set, plan and dose cube and completed plan assessment form (PAF) | |
| Dosimetry | | ||
| QA Streamlining | | Plato |
RTTQA contact: CORINTH.RTTQA@wales.nhs.uk
Chief investigator: Marcia Hall marcia.hall@nhs.net
Sponsor: Cardiff University (corinth@cardiff.ac.uk)
Funder: Merck Sharp and Dohme (MSD#3475-625)