Contact information
Type
Scientific
Contact name
Prof Peter J Hoskin
ORCID ID
Contact details
Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
Northwood
HA6 2RN
United Kingdom
+44 (0)1923 844533
peterhoskin@nhs.net
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT00727584
Protocol/serial number
BRD/07/010
Study information
Scientific title
A randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression
Acronym
SCORAD feasibility study
Study hypothesis
To examine whether a phase III randomised trial comparing a single fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and patients.
Ethics approval(s)
Cornwall and Plymouth Research Ethics Committee approved before patient recruitment began, ref: 07/H0203/167
Study design
Randomized controlled feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Metastatic spinal cord compression
Intervention
Radiotherapy (single or multiple fractions):
Arm 1: 20 Gy/5 fractions daily for 5 consecutive days
Arm 2: 8 Gy/1 fraction
Intervention type
Other
Primary outcome measure
Patient accrual per centre over a 12-month period.
Secondary outcome measures
1. Ambulatory status at 1, 4, 8 and 12 weeks from day 1 of treatment compared to baseline
2. Bladder and bowel function at baseline compared to week 1, 4, 8 and 12
3. Acute side effects at week 1 and 4 assessed using Radiation Therapy Oncology Group (RTOG) scales
4. Quality of life at week 1, 4, 8 and 12, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) questionnaire
5. Further treatment
6. Overall survival at 3, 6 and 12 months
7. Total number of days spent in hospital
8. Preferred place of care
9. Number of patients who were eligible but not randomised and reasons for non-randomisation
Overall study start date
01/03/2008
Overall study end date
31/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Proven diagnosis of spinal cord compression on magnetic resonance imaging (MRI)
2. Histologically or cytologically confirmed malignant disease
3. Life expectancy greater than 1 month
4. Aged 18 years or older
5. Able to give informed consent
6. Willing and able to complete assessment forms
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
100
Total final enrolment
686
Participant exclusion criteria
1. Patients for whom surgery or chemotherapy treatment is more appropriate
2. Patient known to be pregnant
Recruitment start date
01/03/2008
Recruitment end date
31/08/2009
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Mount Vernon Hospital
Northwood
HA6 2RN
United Kingdom
Sponsor information
Organisation
University College London (UCL) (UK)
Sponsor details
Medical School Administration
Gower Street
London
WC1E 6BT
England
United Kingdom
Sponsor type
University/education
Website
http://www.ucl.ac.uk/cancertrials/
ROR
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C2422/A7932)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/12/2019 | 04/01/2021 | Yes | No |
| Plain English results | 26/10/2022 | No | Yes | ||
| Results article | Quality-of-life outcomes | 05/05/2024 | 07/05/2024 | Yes | No |