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 |
| Secondary identifying numbers | 19934 |
- Submission date
- 23/12/2015
- Registration date
- 23/12/2015
- Last edited
- 06/09/2024
- 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
| Study design | Parallel group phase III multi-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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. |
| Intervention type | Other |
| Primary outcome measure | Swallowing function, measured using the MD Anderson Dysphagia Inventory (MDADI) composite score at 12 months after treatment completion |
| Secondary outcome measures | 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 |
| Overall study start date | 18/12/2013 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 102; UK Sample Size: 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
- England
- Ireland
- Northern Ireland
- Scotland
- Syria
- United Kingdom
- Wales
Study participating centres
London
SW3 6JJ
United Kingdom
Sutton
SM2 5PT
United Kingdom
Belfast
BT9 7AB
United Kingdom
Bristol
BS2 8ED
United Kingdom
London
SE1 7EH
United Kingdom
Sheffield
S5 7AU
United Kingdom
Headington
Oxford
Oxford
OX3 7LE
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Worcester
WR5 1DD
Syria
Norwich
NR4 7UY
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Avon
BA1 3NG
United Kingdom
Cardiff
CF14 2TL
United Kingdom
Exeter
EX2 5DW
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
Southampton
SO16 6YD
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Glasgow
G12 0YN
United Kingdom
Inverness
IV2 3UJ
United Kingdom
Torquay
TQ2 7AA
United Kingdom
Dublin
-
Ireland
Sponsor information
Hospital/treatment centre
Fulham Road
London
London
SW3 6JJ
England
United Kingdom
| Website | http://www.royalmarsden.nhs.uk/pages/home.aspx |
|---|---|
"ROR" |
https://ror.org/0008wzh48 |
Research organisation
Innovation House
Old Finglas Road
Dublin
-
Ireland
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication of trial results in a peer-reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| 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 | ||
| Results article | 06/07/2023 | 10/07/2023 | Yes | No | |
| Plain English results | 06/09/2024 | No | Yes |
Editorial Notes
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.
