PEARL: PET-based adaptive radiotherapy clinical trial

Not Applicable

• Conditions: Human Papilloma Virus (HPV)-positive oropharyngeal cancer.; Cancer

• Registration Number: ISRCTN53390753
• Lead Sponsor: Velindre NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-10
• Last Update Posted: 24 January 2022
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

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
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

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. Women who are pregnant or breastfeeding and patients with reproductive potential (male or female) who are
sexually active during the duration of the trial and do not consent to use highly effective method of contraception for at
least 6 months after the last dose of chemoradiotherapy
12. Tumour non-avid on PET-CT or not visible on cross sectional imaging

Study & Design

• Study Type: Interventional
• Study Design: Not specified