Topic: Cancer
Conditions
Interventions
Participants are randomly allocated to one of two groups:
Group 1: Participants receive dysphagia optimised intensity modulated radiotherapy (Do-IMRT)
Group 2: Participants receive standard intensity
however, in Do-IMRT patients, the irradiation of the pharyngeal muscles will be reduced by delivering inverse planned IMRT identifying these as organs at risk. Patients in both treatment groups will r
Sponsors
Royal Marsden NHS Foundation Trust
Cancer Trials Ireland
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 29/08/2017: 1. Aged 18 years or above 2. Any patient undergoing radiotherapy for head and neck cancer in the oropharynx or hypopharynx. Patients with tumour at other sites (*1) where the radical radiotherapy dose is to be delivered to the pharyngeal constrictors may also be eligible 3. Stage T1-4, N0-3, M0 disease; this will be mostly histologically confirmed squamous cell carcinoma (SCC) but other histological types (*1) may be eligible 4. Radiotherapy with concomitant chemotherapy (unless conta -indicated) is the planned treatment 5. WHO performance status 0 or 1 6. Must be available to attend long term follow up 7. Adequate cognitive ability to complete the MDADI, UWQoL and PSSHN assessments 8. Written informed consent *1 Sites are requested to confirm eligibility with ICR-CTSU prior to registration. Previous inclusion criteria: 1. Aged 18 years or above 2. Any patient undergoing radiotherapy for head and neck cancer in the oropharynx or hypopharynx. Patients with tumour at other sites (*1) where the radical radiotherapy dose is to be delivered to the pharyngeal constrictors may also be eligible 3. Stage T1-4, N0-3, M0 disease; this will be mostly histologically confirmed squamous cell carcinoma (SCC) but other histological types (*2) may be eligible 4. Radiotherapy with concomitant chemotherapy (unless conta -indicated) is the planned treatment 5. Creatinine clearance (=50mL/min prior to starting chemotherapy) (*2) 6. WHO performance status 0 or 1 7. Must be available to attend long term follow up 8. Adequate cognitive ability to complete the MDADI, UWQoL and PSSHN assessments 9. Written informed consent *1 Sites are requested to confirm eligibility with ICRCTSU prior to registration *2 Not applicable for patients receiving radiotherapy only
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 29/08/2017: 1. Documented evidence of pre-existing swallowing dysfunction (not related to head and neck cancer) 2. Previous radiotherapy to the head and neck region 3. Posterior pharyngeal wall, post cricoid or retropharyngeal lymph node involvement 4. Lateralised tumours, requiring unilateral neck irradiation 5. Major head and neck surgery (excluding biopsies/tonsillectomy) 6. Current/previous tracheostomy placement 7. Previous or concurrent illness, which in the investigator’s opinion would interfere with completion of therapy, trial assessments or follow up 8. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma) Previous exclusion criteria: 1. Documented evidence of pre-existing swallowing dysfunction (not related to head and neck cancer) 2. Previous radiotherapy to the head and neck region 3. Posterior pharyngeal wall, post cricoid and retropharyngeal lymph node involvement 4. Major head and neck surgery (excluding biopsies/tonsillectomy/neck dissection) 5. Current/previous tracheostomy placement 6. Previous or concurrent illness, which in the investigator’s opinion would interfere with completion of therapy, trial assessments or follow up 7. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Swallowing function, measured using the MD Anderson Dysphagia Inventory (MDADI) composite score at 12 months after treatment completion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Longitudinal pattern of patient-reported swallowing function, assessed by using the MDADI at baseline, 3, 6, 12, 18 and 24 months post treatment 2. Diet and eating habits, assessed by using the Performance Status Scale for Head and Neck Cancer (PSS-HN) at baseline, 3, 6, 12, 18 and 24 months post treatment 3. Swallowing function, assessed using the 100mL water swallow test and videofluoroscopic examination at baseline, 3, 6, 12, 18 and 24 months post treatment 4. Acute and late toxicity and use of feeding tube, assessed at baseline, weekly during radiotherapy at 1, 2, 3, 4 and 8 weeks post radiotherapy and then at 3, 6, 12, 18 and 24 months post treatment 5. Cancer-related outcomes, including resection rates, location and timing of loco-regional tumour recurrence and overall survival, assessed at follow-up visits 3, 6, 12, 18 and 24 months post treatment and then annually until 5 years post treatment | — |
Countries
England, Ireland, Northern Ireland, Scotland, Syria, United Kingdom, Wales
Contacts
Public ContactMark Sydenham
Outcome results
None listed