Condition category
Cancer
Date applied
23/12/2015
Date assigned
23/12/2015
Last edited
29/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Kathrin Mertens

ORCID ID

Contact details

The Institute of Cancer Research
Clinical Magnetic Resonance
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

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

First MREC, 16/11/2015, ref: 15/LO/1464

Study design

Parallel group phase III multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial 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 65Gy in 30 fractions (2.167Gy per fraction) to primary and nodal tumour (PTV_6500) and 54Gy in 30 fractions (1.8Gy 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

Phase

Drug names

Primary outcome measures

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 trial start date

18/12/2013

Overall trial end date

31/07/2023

Reason abandoned

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 (*2) 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 ICRCTSU prior to registration
*2 Not applicable for patients receiving radiotherapy only

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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 102; UK Sample Size: 102

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

31/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Marsden Hospital, Chelsea
Fulham Road
London
SW3 6JJ
United Kingdom

Trial participating centre

Royal Marsden Hospital, Sutton
Downs Road
Sutton
SM2 5PT
United Kingdom

Trial participating centre

Belfast City Centre Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom

Trial participating centre

Bristol Haematology and Oncology Centre
Horfield Road
Bristol
BS2 8ED
United Kingdom

Trial participating centre

Guy’s and St Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Weston Park Hospital
Whitham Road
Sheffield
S5 7AU
United Kingdom

Trial participating centre

The Churchill Hospital, Oxford
Old Road Headington Oxford
Oxford
OX3 7LE
United Kingdom

Trial participating centre

Royal Shrewsbury Hospital
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom

Trial participating centre

Worcester Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
Syria

Trial participating centre

Norfolk & Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom

Trial participating centre

Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Trial participating centre

Royal United Hospitals Bath
Combe Park
Avon
BA1 3NG
United Kingdom

Trial participating centre

Velindre Cancer Centre
Velindre Road
Cardiff
CF14 2TL
United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Western General Hospital
Crewe Road S
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

Royal Marsden NHS Foundation Trust

Sponsor details

Fulham Road
London
London
SW3 6JJ
United Kingdom

Sponsor type

Hospital/treatment centre

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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27716125

Publication citations

Additional files

Editorial Notes

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.