Oropharyngeal cancer
Participants will be recruited from selected sites across the UK. Potential participants will be identified by their clinical care teams and their suitability will be discussed at local multidisciplinary team meetings. Participants will have locally advanced oropharyngeal squamous cell carcinoma prostate cancer and have opted to have chemo-radiotherapy as radical treatment. Participants will be approached by a member of their clinical care team and will receive a verbal explanation of the trial, together with a Patient Information Sheet which they will take home with them. They will be given sufficient time to make a decision about whether they would like to participate and will be able to discuss their options with friends, family or their GP. They will have the opportunity to raise any questions about TORPEdO with their clinical care or research team and these will be addressed prior to their decision about whether to participate. Should they chose to participate they will be asked to sign a consent form to record their informed consent. All participants will be randomised via the central randomisation service provided by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU). Participants will be randomised using a computer-generated minimisation technique which ensures balance between the treatment groups. Using this technique, the treatment allocation for each participant depends on the characteristics of the participants already involved, thus minimising imbalance across any factors that might predict outcome. The following assessments will be performed prior to randomisation into TORPEdO: a) Complete medical history, physical examination (including weight and height), WHO performance status (PS) b) Pre-radiotherapy dental assessment (may be conducted at randomising centre or proton centre) c) Blood to be taken for full blood count, renal function (calculated GFR/isotope depending on local hospital policy) electrolytes and li
1. Histologically confirmed oropharyngeal squamous cell carcinoma 2. HPV positive TNM8: T1-2 N1-2 (excluding T1-2 with a single ipsilateral node < 3cm), T3-4 N0-2 3. HPV negative TNM 8: T1N2, T2N1-N2, T3-4N0-2 4. Local MDT decision for concurrent chemoradiotherapy with bilateral neck treatment 5. Age >=18 years 6. WHO performance status 0-1 7. Adequate renal function, glomerular filtration rate (GFR) > 60ml/min calculated using Cockcroft-Gault formula 8. Adequate cognitive ability (in the opinion of the local PI) to complete PRO assessments 9. Willingness to comply with the protocol, including travel to the proton centre for IMPT treatment 10. Written informed consent
1. Feeding tube insertion required for nutrition due to dysphagia prior to treatment [Note: patients who have prophylactic feeding tube insertion, with or without tube use to top up nutrition prior to starting treatment, remain eligible for the study] 2. N3 disease 3. Upfront neck dissection 4. Use of induction chemotherapy 5. Previous head and neck radiotherapy 6. Major surgery within 6 months of trial entry 7. Permanent pacemaker or implantable cardioverter-defibrillator 8. Any invasive malignancy within previous 2 years (other than non-melanomatous skin carcinoma or cervical carcinoma in situ) 9. Previous or concurrent illness (e.g., active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis), which in the investigator’s opinion would interfere with completion of therapy, trial assessments or follow up 10. Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active) 11. Pre-existing speech or swallowing problems unrelated to the diagnosis of cancer For patients taking part in the optional DW-MRI study at The Christie Hospital the following additional exclusion criteria apply: 1. Any contraindication to MRI scanning, including metallic heart valve replacement, permanent pacemaker, implantable cardiac defibrillator, non-MRI compatible metal implants, neuro-stimulators 2. A history of allergy/reaction to Gadolinium contrast