Condition category
Cancer
Date applied
10/05/2004
Date assigned
22/06/2004
Last edited
19/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Martin Birchall

ORCID ID

Contact details

Clinical Sciences Centre
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00334997

Protocol/serial number

N/A

Study information

Scientific title

EaStER: Early Stage glottic laryngeal cancer: Endoscopic excision or Radiotherapy? - a feasibility study

Acronym

EaStER

Study hypothesis

The EaStER study applies only to patients with glottic cancer. This feasibility study is being carried out to determine whether it will be possible to conduct a large phase III trial to evaluate the outcome of patients treated with either endoscopic excision or standard radiotherapy. Outcome will be measured in terms of clinical outcome, voice quality, and quality of life. An economic assessment will also be carried out to determine the relative cost of each type of treatment to both patients and the NHS. Five centres are currently participating in this study. Data will be collected on the number of eligible patients approached, the number who agree to be registered into the voice/quality of life research, and the number who agree to be randomised for treatment. Patients who agree to take part in an associated qualitative research programme will also provide valuable data on patients' views on randomisation. The results of the feasibility study will determine whether it will be possible to recruit the required number of patients into an identical main trial within the UK.

Ethics approval

Not provided at time of registration.

Study design

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

Early stage glottic cancer

Intervention

Endoscopic excision or standard radiotherapy

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2005

Overall trial end date

31/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed squamous cell carcinoma of the glottic larynx, including tumours at the anterior commisure
2. Stage Tis, T1, T2a, N0, M0
3. Anatomy of airways suitable for endoscopic excision
4. Fit to receive radical treatment as either radiotherapy or endoscopic excision
5. Age 18 years or greater
6. Willing to participate in a recruitment appointment
7. Willing to complete voice and quality of life questionnaires
8. Available for follow up within the UK

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Any clinical or radiological sign of nodal involvement
2. Any evidence of clinical metastases
3. Any previous cancer within 10 years (except basal cell carcinoma of the skin and adequately treated carcinoma-in-situ of the uterine cervix)
4. Concomitant chemotherapy
5. Patients with vasculitic conditions adversely affecting radiotherapy
6. Pregnancy
7. Other co-existing medical condition such that life expectancy is less than two years
8. Treatment with palliative intent

Recruitment start date

01/08/2005

Recruitment end date

31/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Aintree
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23334205

Publication citations

Additional files

Editorial Notes