Plain English Summary
Study website
Contact information
Type
Scientific
Contact name
Mr Mark Sydenham
ORCID ID
Contact details
DARS Trial Manager
ICR-Clinical Trials and Statistics Unit
Division of Clinical Studies
Institute of Cancer Research
Cotswold Road
Sutton
SM2 4NG
United Kingdom
+44 (0)208 722 4104
DARS-icrctsu@icr.ac.uk
Type
Public
Contact name
Mr Mark Sydenham
ORCID ID
Contact details
DARS Trial Manager
ICR-Clinical Trials and Statistics Unit
Division of Clinical Studies
Institute of Cancer Research
Cotswold Road
Sutton
SM2 4NG
United Kingdom
+44 (0)208 722 4104
DARS-icrctsu@icr.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
19934
Study information
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
Acronym
DARS
Study hypothesis
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
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
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Overall study end date
31/07/2023
Reason abandoned (if study stopped)
Eligibility
Participant 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
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
Participant 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)
Recruitment start date
20/05/2016
Recruitment end date
27/04/2018
Locations
Countries of recruitment
England, Ireland, Northern Ireland, Scotland, Syria, United Kingdom, Wales
Study participating centre
Royal Marsden Hospital, Chelsea
Fulham Road
London
SW3 6JJ
United Kingdom
Study participating centre
Royal Marsden Hospital, Sutton
Downs Road
Sutton
SM2 5PT
United Kingdom
Study participating centre
Belfast City Centre Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Study participating centre
Bristol Haematology and Oncology Centre
Horfield Road
Bristol
BS2 8ED
United Kingdom
Study participating centre
Guy’s and St Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study participating centre
Weston Park Hospital
Whitham Road
Sheffield
S5 7AU
United Kingdom
Study participating centre
The Churchill Hospital, Oxford
Old Road
Headington
Oxford
Oxford
OX3 7LE
United Kingdom
Study participating centre
Royal Shrewsbury Hospital
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom
Study participating centre
Worcester Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
Syria
Study participating centre
Norfolk & Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Study participating centre
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Study participating centre
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Study participating centre
Royal United Hospitals Bath
Combe Park
Avon
BA1 3NG
United Kingdom
Study participating centre
Velindre Cancer Centre
Velindre Road
Cardiff
CF14 2TL
United Kingdom
Study participating centre
Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
Study participating centre
Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
United Kingdom
Study participating centre
Western General Hospital
Crewe Road S
Edinburgh
EH4 2XU
United Kingdom
Study participating centre
University Hospital Southampton
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study participating centre
Derriford Hospital, Plymouth
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom
Study participating centre
Beatson West of Scotland Cancer Centre,
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Study participating centre
Riagmore Hospital
Old Perth Road
Inverness
IV2 3UJ
United Kingdom
Study participating centre
Torbay Hospital
Lowes Bridge
Torquay
TQ2 7AA
United Kingdom
Study participating centre
St Luke’s Hospital
St Luke’s Radiation Oncology Network
Dublin
-
Ireland
Sponsor information
Organisation
Royal Marsden NHS Foundation Trust
Sponsor details
Fulham Road
London
London
SW3 6JJ
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
http://www.royalmarsden.nhs.uk/pages/home.aspx
ROR
Organisation
Cancer Trials Ireland
Sponsor details
Innovation House
Old Finglas Road
Dublin
-
Ireland
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication of trial results in a peer-reviewed journal.
Intention to publish date
31/12/2021
Individual participant data (IPD) Intention to share
No
IPD sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |