PEARL PET-based Adaptive Radiotherapy Clinical Trial

Launched by VELINDRE NHS TRUST · Apr 30, 2019

Keywords

ClinConnect Summary

PEARL is a prospective, interventional, non-randomised, phase II feasibility study for patients with good prognosis Human Papillomavirus (HPV)-associated oropharyngeal squamous cell cancer (OPSCC) who are suitable for treatment with concurrent chemo-radiotherapy (CCRT).

The incidence of oropharyngeal squamous cell carcinoma (OPSCC) caused by Human Papillomavirus (HPV) infection (HPV-positive OPSCC) is increasing in the United Kingdom. It tends to affect younger patients and has a better outcome than most other head and neck cancers.

A large proportion of patients diagnosed with HPV-positi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed squamous cell carcinoma of the oropharynx
• • 2. Positive p16 Immunohistochemistry on local testing
• • 3. UICC TNM (8th edition) stage T1 - T3 N0 - N1 M0
• • 4. Multidisciplinary team (MDT) decision to treat with primary chemoradiotherapy
• • 5. Patients considered fit for radical treatment with primary chemoradiotherapy (including sufficient renal function (GFR\>50ml/min)
• • 6. Aged 18 years or older
• • 7. Not smoked in the last 2 years
• • 8. Written informed consent provided
• • 9. 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:
• • 1. Known HPV negative squamous cell carcinoma of the head and neck
• • 2. T1 - T3 tumours where primary treatment with concomitant chemo-radiotherapy is not considered appropriate
• • 3. T4 disease
• • 4. N2 (TMN8) nodal disease
• • 5. Distant metastatic disease
• • 6. Current smokers or smokers who have stopped within the past 2 years
• • 7. Diabetes mellitus
• • 8. Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer
• • 9. Previous radiotherapy to the head and neck
• • 10. History of malignancy in the last 5 years, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix
• • 11. Tumour non-avid on PET-CT or not visible on cross sectional imaging