EaStER: Early Stage glottic laryngeal cancer: Endoscopic excision or Radiotherapy? - a feasibility study
| ISRCTN | ISRCTN17541410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17541410 |
| ClinicalTrials.gov number | NCT00334997 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/05/2004
- Registration date
- 22/06/2004
- Last edited
- 19/11/2015
- 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
Contact information
Prof Martin Birchall
Scientific
Scientific
Clinical Sciences Centre
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
Study information
| Study design | 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 | EaStER: Early Stage glottic laryngeal cancer: Endoscopic excision or Radiotherapy? - a feasibility study |
| Study acronym | EaStER |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Early stage glottic cancer |
| Intervention | Endoscopic excision or standard radiotherapy |
| Intervention type | Mixed |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2005 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospital Aintree
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Charity
Cancer Research UK
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2013 | Yes | No |
