Oropharyngeal cancer, stage III/IVa/IVb Cancer
Conditions
Interventions
Potentially eligible patients will be identified and assessed by the clinician coordinating their care or delegated members of the research team. Potential participants will be given sufficient time (
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed HPV-negative oropharyngeal squamous cell carcinoma (OPSCC) or HPV-positive OPSCC and significant smoking history (>20 pack years) within the past 20 years 2. Stage III, IVa or IVb OPSCC 3. Scheduled for single modality photon radiotherapy as primary radical treatment 4.18 years old and over 5. Able to give informed consent 6. Patients willing and able to comply with the protocol for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Head and neck cancers from sub-sites other than oropharynx 2. HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) in patients with no significant smoking history (low-risk OPSCC) 3. Confirmed distal metastatic disease (stage IVc) 4. Patients who have undergone primary surgery for OPSCC (including neck dissection) 5. Patients who have received induction chemotherapy prior to definitive treatment 6. Patients receiving chemoradiotherapy or cetuximab-radiotherapy 7. Prior radiotherapy to the head and neck region 8. Patients with contra-indications to MRI scanning 9. Patients who do not adequately understand verbal or written information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients able to complete diffusion-weighted (DW)-magnetic resonance imaging (MRI)-guided response-adapted radiotherapy measured by 50% of patients having completed DW-MRI guided response adapted RT at the end of the study as per data collected in the study database | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the outcomes of patients undergoing DW-MRI guided radiotherapy as follows: 1. The proportion of Grade 3+ acute toxicity rates, comparing dose-escalated and standard RT cohorts, measured using data collected in the study database for analysis. Toxicity and adverse events will be collected and recorded throughout treatment, at the end of treatment, post-treatment and at 3 and 6 months after completion of treatment. 2. Patient-reported quality of life scores, comparing dose-escalated and standard RT cohorts, measured using data collected in the study database for analysis prior to treatment, at the end of treatment, 4 weeks post-treatment, and 3 months and 6 months after completion of treatment 3. Loco-regional control rates at 12 and 24 months, overall survival, and cancer-specific survival, comparing dose-escalated and standard RT cohorts, measured using data from medical records at 12 and 24 months after completion of treatment | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactAnn Shaw
Outcome results
None listed