PEARL PET-based Adaptive Radiotherapy Clinical Trial (PEARL)
Oropharyngeal Cancer
About this trial
This is an interventional treatment trial for Oropharyngeal Cancer focused on measuring Oropharyngeal Cancer, Radiotherapy, HPV positive, Automated segmentation, Radiotherapy re-planning
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed squamous cell carcinoma of the oropharynx
- Positive p16 Immunohistochemistry on local testing
- UICC TNM (8th edition) stage T1 - T3 N0 - N1 M0
- Multidisciplinary team (MDT) decision to treat with primary chemoradiotherapy
- Patients considered fit for radical treatment with primary chemoradiotherapy (including sufficient renal function (GFR>50ml/min)
- Aged 18 years or older
- Not smoked in the last 2 years
- Written informed consent provided
- Patients with reproductive potential (male or female), who are sexually active during the duration of the trial consent to using a highly effective method of contraception for at least six months after the last dose of chemoradiotherapy. Effective forms of contraception are described in section 15.5.
Exclusion Criteria:
- Known HPV negative squamous cell carcinoma of the head and neck
- T1 - T3 tumours where primary treatment with concomitant chemo-radiotherapy is not considered appropriate
- T4 disease
- N2 (TMN8) nodal disease
- Distant metastatic disease
- Current smokers or smokers who have stopped within the past 2 years
- Diabetes mellitus
- Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer
- Previous radiotherapy to the head and neck
- History of malignancy in the last 5 years, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix
- Tumour non-avid on PET-CT or not visible on cross sectional imaging
Sites / Locations
- Velindre Cancer Center at Velindre Hospital
- Singleton Hospital
- University Hospitals Bristol NHS Foundation Trust
Arms of the Study
Arm 1
Other
All trial participants
Baseline plasma and saliva tests for future translational analysis Baseline planning FDG PET CT scan Patients will start their 6 weeks of CCRT within two to three weeks following the planning scans. Cisplatin chemotherapy will be administered. 33 daily fractions of radiotherapy will be delivered over 6 weeks. A second FDG-PET-CT scan (iPET) and repeat plasma and saliva tests will be carried out after 2 weeks of CCRT (on RT days 9 - 12) and the iPET assessed for residual FDG-avid disease. The biological GTV will be re-outlined based on the residual avid region of the tumour on the second PET-CT (bGTV_iP) At the end of treatment, plasma and saliva tests will be carried out at 4 weeks post treatment and again at the 3 month post-treatment PET-CT Swallowing and QoL assessments will be repeated 4 weeks (+/- 2 weeks) after treatment and will be repeated at 6, 12 and 24 months post-treatment. The plasma and saliva samples will be repeated at 12 and 24 months