Condition category
Cancer
Date applied
17/01/2011
Date assigned
31/03/2011
Last edited
28/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Christopher Nutting

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICR-CTSU/2009/10022

Study information

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

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

Central London Research Ethics Committee (REC) 4 approved on 18/10/2010 (ref: 10/H0715/48)

Study design

Parallel group phase III multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/02/2011

Overall trial end date

07/03/2020

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

354

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

07/03/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Director Head and Neck Unit, Consultant Reader in Oncology
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

Royal Marsden NHS Foundation Trust (UK)

Sponsor details

Fulham Road
London
SW3 6JJ
United Kingdom

Sponsor type

Government

Website

http://www.royalmarsden.nhs.uk/home

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: CRUK/10/018)

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes