Dose escalated intensity modulated radiotherapy versus standard dose intensity modulated radiotherapy in laryngeal and hypopharyngeal cancer patients

ISRCTN	ISRCTN01483375
DOI	https://doi.org/10.1186/ISRCTN01483375
Protocol serial number	ICR-CTSU/2009/10022
Sponsor	Royal Marsden NHS Foundation Trust (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: CRUK/10/018)

Submission date: 17/01/2011
Registration date: 31/03/2011
Last edited: 27/11/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-study-looking-increasing-dose-radiotherapy-treat-cancer-voice-box-or-lower-part-of-the-throat-art-deco

Contact information

Dr Christopher Nutting
Scientific

Director Head and Neck Unit, Consultant Reader in Oncology
Royal Marsden NHS Foundation Trust
Head and Neck Unit
Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Parallel group phase III multicentre randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised multicentre accelerated radiotherapy study of dose escalated intensity modulated radiotherapy versus standard dose intensity modulated radiotherapy in patients receiving treatment for locally advanced laryngeal and hypopharyngeal cancers
Study acronym	ART-DECO
Study objectives	To determine the potential of dose escalated intensity modulated radiotherapy (IMRT) to improve locoregional failure free rate (LRFFR) and laryngeal preservation in patients with locally advanced laryngeal and hypopharyngeal cancers, without increasing the incidence of severe acute and late toxicities to unacceptable levels.
Ethics approval(s)	Central London Research Ethics Committee (REC) 4 approved on 18/10/2010 (ref: 10/H0715/48)
Health condition(s) or problem(s) studied	Locally advanced squamous cell cancers of the larynx or hypopharynx
Intervention	The dose escalated IMRT (experimental) treatment group will receive 67.2 Gy in 28 fractions (2.4 Gy per fraction) to the involved site and nodal groups and 56 Gy in 28 fractions (2.0 Gy per fraction) to nodal areas at risk of harbouring microscopic disease. The standard dose IMRT (standard) treatment group will receive 65 Gy in 30 fractions (2.167 Gy per fraction) to the involved site and nodal groups and 54 Gy in 30 fractions (1.8 Gy per fraction) to nodal areas at risk of harbouring microscopic disease. All patients will receive concomitant cisplatin 100 mg/m2 on day 1 and day 29 of the radiotherapy schedule however within the context of this trial, chemotherapy is not an investigational medicinal product. 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)	Locoregional failure free rate (LRFFR). Measured at 1, 2, 3, 4 and 8 weeks post-treatment and at 3, 6, 12, 18 and 24 months post treatment. Patients will then be followed up annually up to 5 years.
Key secondary outcome measure(s)	1. Laryngo-oesophageal dysfunction free rate 2. Overall survival (time from randomisation to death) 3. Acute and late toxicities following chemoradiation 4. Characteristics of patients who proceed to salvage neck dissection 5. Characteristics of patients who fail organ preservation All of the above will be measured at 1, 2, 3, 4 and 8 weeks post-treatment and at 3, 6, 12, 18 and 24 months post treatment. Patients will then be followed up annually up to 5 years. 6. Patient assessed quality of life, measured using questionnaires administered at baseline, end of radiotherpay treatment, 6 months, 1 year and then annually to 5 years post-treatment
Completion date	01/12/2020

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	16 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	354
Total final enrolment	276
Key inclusion criteria	1. Aged 16 years or above, either sex 2. Histologically confirmed squamous cell cancer of the larynx or hypopharynx 3. Chemo-radiotherapy is the investigators treatment of choice. Induction chemotherapy is permitted. 4. Locally advanced squamous cell cancer of the larynx or hypopharynx i.e. stage III or IV a/b disease 5. World Health Organization (WHO) performance status of 0 or 1 6. Creatinine clearance of greater than 50 ml/min 7. Must be suitable to attend long term follow-up. All patients participating in the QoL study must have adequate cognitive ability to complete the QoL questionnaires. 8. Written informed consent Patients may undergo surgical biopsy or non-radical surgery prior to study entry.
Key exclusion criteria	1. Previous radiotherapy to the head and neck region 2. Clinical evidence of metastatic disease (Stage IVc) 3. Previous malignancy except non-melanoma skin cancer and early stage cancer in remission for at least 5 years following treatment 4. Previous or concurrent illness, which in the investigator's opinion would interfere with completion of therapy 5. Pre-existing previous speech or swallowing problems unrelated to the diagnosis of cancer 6. Large primary tumour, where organ preservation is unrealistic
Date of first enrolment	01/02/2011
Date of final enrolment	20/10/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Head and Neck Unit

-
London
SW3 6JJ
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		10/07/2021	14/07/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results		10/03/2022	24/03/2022	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/11/2025: The interventions were updated.
24/03/2022: The Cancer Research UK lay results summary has been added.
14/07/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
20/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 07/03/2020 to 20/10/2015.
2. The overall trial end date was changed from 07/03/2020 to 01/12/2020.