Contact information
Type
Scientific
Primary contact
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 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.
As of 29/04/2008 the anticipated start and end dates of this trial were updated. The initial anticipated start and end dates of this trial were:
Anticipated start date: 11/11/2007
Anticipated end date: 11/11/2008
As of 12/05/2009 the anticipated end date of this trial was again extended; the previous anticipated end date was 21/02/2009.
Ethics approval
Cornwall and Plymouth Research Ethics Committee approved before patient recruitment began (ref: 07/H0203/167)
Study design
Randomised controlled feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/03/2008
Overall trial end date
31/08/2009
Reason abandoned
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
Patient
Age group
Adult
Gender
Both
Target number of participants
100
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
United Kingdom
Trial participating centre
Marie Curie Research Wing
Northwood
HA6 2RN
United Kingdom
Sponsor information
Organisation
University College London (UCL) (UK)
Sponsor details
Medical School Administration
Gower Street
London
WC1E 6BT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C2422/A7932)
Alternative name(s)
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