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 |
| Secondary identifying numbers | ICR-CTSU/2009/10022 |
- Submission date
- 17/01/2011
- Registration date
- 31/03/2011
- Last edited
- 24/03/2022
- 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
Contact information
Dr Christopher Nutting
Scientific
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
| Study design | Parallel group phase III multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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) |
| Condition | 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. |
| Intervention type | Other |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/02/2011 |
| Overall study end date | 01/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 354 |
| Total final enrolment | 276 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 01/02/2011 |
| Recruitment end date | 20/10/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Head and Neck Unit
London
SW3 6JJ
United Kingdom
SW3 6JJ
United Kingdom
Sponsor information
Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Fulham Road
London
SW3 6JJ
England
United Kingdom
| Website | http://www.royalmarsden.nhs.uk/home |
|---|---|
"ROR" |
https://ror.org/0008wzh48 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: CRUK/10/018)
Private sector organisation / Other non-profit organizations
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 | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/07/2021 | 14/07/2021 | Yes | No | |
| Plain English results | 10/03/2022 | 24/03/2022 | No | Yes |
Editorial Notes
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.
