Oropharyngeal cancer Cancer Malignant neoplasm of oropharynx
Conditions
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed oropharyngeal squamous cell carcinoma 2. HPV positive TNM8: T1-2 N1-2 (excluding T1-2 with a single ipsilateral node =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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoints: 1. University of Washington Quality of Life Questionnaire (UW-QoL) physical composite score 2. Gastrostomy dependence or CTCAE grade 3 weight loss (i.e. = 20% weight loss from baseline) Timepoint(s): 12 months after completion of chemoradiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life (HR-QoL) evaluated using the PRO questionnaires at baseline, end of treatment, 6 weeks post-treatment and at 3, 6, 12, 18, 24, 36, 48, and 60 months post-treatment 1.1. University of Washington Quality of Life (UW-QoL) 1.2. EORTC QLQ-C30 and QLQ-H&N43 1.3. M.D. Anderson Dysphagia Inventory (MDADI) 2. Tube feeding status evaluated at 3, 12, 18 and 24 months after completion of treatment 3. Acute and late severe toxicity assessed by physician recorded CTCAE v 5.0 and physician-rated dysphagia scores at baseline, week 1, week 2, week 3, week 4, week 5, week 6 (during treatment) week 7 (end of treatment), 3, 6, 12, 18 and 24 months post-treatment 4. Swallowing function evaluated using the 100-mL Water Swallowing Test at baseline, and at 3, 6, 12, 18 and 24 months following completion of study treatment 5. Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet and Place of Eating scores reported at baseline, and at 3, 6, 12, 18 and 24 months following completion of study treatment 6. Hearing measured by audiometry at baseline, and at 3, 12 and 24 months post-treatment 7. Trismus evaluated using change in maximum interincisal distance at baseline, and at 3, 12 and 24 months post-treatment 8. Resection rate, defined as the proportion of patients proceeding to surgical treatment (including neck dissection) after the completion of radiotherapy treatment 9. Loco-regional tumour control, defined as time from randomisation to loco-regional recurrence i.e. recurrence at the primary site or in the neck 10. Overall survival, defined as time from randomisation to death from any cause 11. Cost-effectiveness analysed using the healthcare resource use questionnaire developed for the trial, Work Productivity Assessment Index (WPAI-SHP) and EuroQol five-dimensional questionnaire (EQ-5D-5L) at baseline, end of treatment, 6 weeks post-treatment and at 3, 6, 12, 18, 24, 36, 48, and 60 months post-treatment | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed