Clinical trial · Interventional
PEARL PET-based Adaptive Radiotherapy Clinical Trial
PEARL: PET-based Adaptive Radiotherapy Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The PEARL study will recruit approximately 50 patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) who are about to undergo primary treatment with concurrent chemo-radiation from South Wales (Velindre Cancer Centre and Singleton Hospital, Swansea) and Bristol. The main aim is to see whether it is feasible to preform a positron emission tomography-computed tomography (PET-CT) scan after 2 weeks of radiotherapy and re-plan the radiotherapy based on this PET-CT scan, to re-distribute the dose of radiotherapy being delivered, so that a smaller area of normal tissues in the mouth and throat are treated to a high dose of radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples for cell-free DNA analysis | Procedure | — | UNRESOLVED |
| Outlining the biological GTVs (bGTV_P and bGTV_iP) | Procedure | — | UNRESOLVED |
| PET-CT scans | Procedure | — | UNRESOLVED |
| Salivary samples for cell-free DNA analysis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- All trial participants
- description
- 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
- interventionNames
- Procedure: PET-CT scans
- Procedure: Outlining the biological GTVs (bGTV_P and bGTV_iP)
- Procedure: Blood samples for cell-free DNA analysis
- Procedure: Salivary samples for cell-free DNA analysis
Primary outcomes (1)
- measure
- Progression free survival at 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available