A study examining whether a new radiotherapy technique (“dysphagia optimised intensity modulated radiotherapy”) will improve swallowing function after treatment in head and neck cancer patients
| ISRCTN | ISRCTN25458988 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25458988 |
| Protocol serial number | 19934 |
| Sponsors | Royal Marsden NHS Foundation Trust, Cancer Trials Ireland |
| Funder | Cancer Research UK |
- Submission date
- 23/12/2015
- Registration date
- 23/12/2015
- Last edited
- 27/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
DARS Trial Manager
ICR-Clinical Trials and Statistics Unit
Division of Clinical Studies
Institute of Cancer Research
Cotswold Road
Sutton
SM2 4NG
United Kingdom
| Phone | +44 (0)208 722 4104 |
|---|---|
| DARS-icrctsu@icr.ac.uk |
Public
DARS Trial Manager
ICR-Clinical Trials and Statistics Unit
Division of Clinical Studies
Institute of Cancer Research
Cotswold Road
Sutton
SM2 4NG
United Kingdom
| Phone | +44 (0)208 722 4104 |
|---|---|
| DARS-icrctsu@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel group phase III multi-centre randomized controlled trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | A phase III randomised multicentre study of dysphagia optimised intensity modulated radiotherapy (Do-IMRT) versus standard intensity modulated radiotherapy (S-IMRT) in head and neck cancer |
| Study acronym | DARS |
| Study objectives | The aim of this study is to investigate whether dysphagia optimised intensity modulated radiotherapy (Do-IMRT) compared to standard IMRT (S-IMRT) improves post radiotherapy swallowing difficulties in patients with head and neck cancer. |
| Ethics approval(s) | First MREC, 16/11/2015, ref: 15/LO/1464 |
| Health condition(s) or problem(s) studied | Topic: Cancer; Subtopic: Head and Neck Cancer; Disease: Head and Neck |
| Intervention | 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 modulated radiotherapy (S-IMRT) Radiotherapy doses will be the same in both groups; 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 receive 65 Gy in 30 fractions (2.167 Gy per fraction) to primary and nodal tumour (PTV_6500) and 54 Gy in 30 fractions (1.8 Gy per fraction) to remaining pharyngeal subsites and nodal areas at risk of harbouring microscopic disease (PTV_5400). Unless contraindicated, patients will receive concomitant chemotherapy. Participants will be followed up after radiotherapy treatment at regular intervals for 24 months, and then annually for up to 5 years. Added 27/11/2025: Additional Data Linkage Information: Participants from this trial will also be included in the INTERACT project which will link to their data held by NHS England. For more information, please see the INTERACT website: https://www.icr.ac.uk/interact. |
| Intervention type | Other |
| Primary outcome measure(s) |
Swallowing function, measured using the MD Anderson Dysphagia Inventory (MDADI) composite score at 12 months after treatment completion |
| Key secondary outcome measure(s) |
1. Longitudinal pattern of patient-reported swallowing function, assessed by using the MDADI at baseline, 3, 6, 12, 18 and 24 months post treatment |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 102 |
| Total final enrolment | 112 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 20/05/2016 |
| Date of final enrolment | 27/04/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
- Ireland
- Syria
Study participating centres
London
SW3 6JJ
England
Sutton
SM2 5PT
England
Belfast
BT9 7AB
Northern Ireland
Bristol
BS2 8ED
England
London
SE1 7EH
England
Sheffield
S5 7AU
England
Headington
Oxford
Oxford
OX3 7LE
England
Shrewsbury
SY3 8XQ
England
Norwich
NR4 7UY
England
Cheltenham
GL53 7AN
England
Gloucester
GL1 3NN
England
Avon
BA1 3NG
England
Cardiff
CF14 2TL
Wales
Exeter
EX2 5DW
England
Nottingham
NG7 2UH
England
Edinburgh
EH4 2XU
Scotland
Southampton
SO16 6YD
England
Crownhill
Plymouth
PL6 8DH
England
Glasgow
G12 0YN
Scotland
Inverness
IV2 3UJ
Scotland
Torquay
TQ2 7AA
England
Worcester
WR5 1DD
Syria
Dublin
-
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/07/2023 | 10/07/2023 | Yes | No | |
| Protocol article | protocol | 06/10/2016 | Yes | No | |
| Abstract results | results presented at ASCO | 20/05/2020 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 06/09/2024 | No | Yes | ||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/11/2025: The interventions were updated.
06/09/2024: Cancer Research UK plain English results link added.
10/07/2023: Publication reference added.
04/05/2021: The previous scientific contact has been deleted and a new public and scientific contact added.
17/07/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
01/05/2018: The recruitment end date has been changed from 31/05/2018 to 27/04/2018.
06/02/2018: Cancer Trials Ireland has been added as the sponsor for the Republic of Ireland only.
01/02/2018: The following sites have been added: University Hospital Southampton, Derriford Hospital, Plymouth, Beatson West of Scotland Cancer Centre, Glasgow, Riagmore Hospital, Inverness, Torbay Hospital and St Luke's Hospital, St Luke’s Radiation Oncology Network, Dublin. A minor correction in the inclusion criteria has been made and the statement "*2 Not applicable for patients receiving radiotherapy only" has been removed.
29/08/2017: Overall trial end date has been changed from 21/02/2021 to 03/07/2023. Recruitment start date has been updated from 04/01/2016 to 20/05/2016. Recruitment end date has been updated from 21/02/2018 to 31/05/2018. Queen Elizabeth Hospital Birmingham has been removed as a trial participating centre. The follow have been added as trial participating centres: The Churchill Hospital, Oxford, Royal Shrewsbury Hospital, Worcester Royal Hospital, Norfolk & Norwich University Hospital, Cheltenham General Hospital, Gloucestershire Royal Hospital, Royal United Hospitals Bath, Velindre Cancer Centre, Royal Devon & Exeter Hospital, Nottingham University Hospital, Western General Hospital, Edinburgh. The sponsor address has been corrected.
10/10/2016: Publication reference added.
24/08/2016: Cancer Help UK lay summary link added.
