A study examining whether a new radiotherapy technique (“dysphagia optimise... | Recruiting
A study examining whether a new rad... | Recruiting
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
DARS

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Topic: Cancer
  • Subtopic: Head and Neck Cancer
  • Disease: Head and Neck
Primary Contact Details
Dr Kathrin Mertens
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN25458988
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-whether-changing-dose-radiotherapy-improves-swallowing-people-head-neck-cancer-dars
Research Details
  • 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.
Phase
Sorry, this information is not available
Study Design
Parallel group phase III multi-centre randomised controlled trial
Study Type
Interventional
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
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
Publication(s)
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27716125
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 102; UK Sample Size: 102
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 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)
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Royal Devon and Exeter Hospital
Exeter
England
EX2 5DW
London
SE1 7EH
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
Nottingham
NG7 2UH
Belfast
BT9 7AB
Novartis Investigative Site
Cheltenham
Gloucestershire
GL53 7AN
Norwich
NR4 7UY
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Bristol
BS2 8ED
Sheffield Kidney Institute
Sheffield
S5 7AU
Churchill Hospital
Oxford
OX3 7LE
Gloucestershire Royal Hospital
Gloucester
England
GL1 3NN
Royal Shrewsbury Hospital
Shrewsbury
England
SY3 8XQ
Combe Park
Avon
BA1 3NG
Charles Hastings Way
Worcester
WR5 1DD
Trial Contact(s)
Primary Trial Contact
Dr Kathrin Mertens
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Cancer Research UK
Other Study ID Numbers
19934
Sponsor(s)
Royal Marsden NHS Foundation Trust
Key Dates

Recruitment Start Date

20 May 2016

Recruitment End Date

31 May 2018

Trial Start Date

18 Dec 2013

Trial End Date

31 Jul 2023

Date added to source

23 Dec 2015

Date updated in source

29 Aug 2017