Contact information
Type
Scientific
Primary contact
Prof Peter Hoskin
ORCID ID
Contact details
Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
HA6 2RN
United Kingdom
+44 1923 844 533
ctc.scorad@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00727584
Protocol/serial number
N/A
Study information
Scientific title
A randomised phase III trial of single fraction radiotherapy compared to multifraction radiotherapy in patients with metastatic spinal cord compression
Acronym
SCORAD III
Study hypothesis
This is a non-inferiority trial to show that ambulatory status using 8 Gy in one fraction is no worse than 20 Gy in five fractions.
Ethics approval
North West London REC 1, 03/11/2009, ref: 09/H0722/76
Study design
Multicentre randomised phase III trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at: http://www.ucl.ac.uk/cancertrials/trials/scorad/SCORAD%20summary%20April%2007.pdf
Condition
Metastatic spinal cord compression
Intervention
Patient randomisation is performed using a 24 hour remote internet based randomisation programme.
Arm 1: External beam multi-fraction radiotherapy: 20Gy/5f
Arm 2: External beam single fraction radiotherapy: 8Gy/1f
Total duration of treatment is approximately one week for Arm 1, and one day for Arm 2.
Follow up for both treatment arms is at 1, 4, 8 and 12 weeks after day 1 of treatment.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Ambulatory status is determined through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at 8 weeks from day 1 of treatment compared to randomisation.
Secondary outcome measures
1. Recovery of and time to ambulation is measured through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at weeks 1, 4, 8, and 12 from day 1 of treatment compared to randomisation
2. Ambulatory status is determined using measured through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at 1, 4, and 12 weeks (where available) compared to randomisation
3. Maintenance of ambulatory status is determined through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at weeks 1, 4, 8, and 12 from day 1 of treatment compared to randomisation
4. Bladder and bowel function is measured through phone interviews with the patient or where this is not possible, reviewing the patient notes, at 1, 4, 8 and 12 weeks from day 1 of treatment compared to randomisation
5. Acute side effects are measured using through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying the Common Terminology Criteria for Adverse Events (CTCAE) scales v4.02 or Radiation Treatment and Oncology Groups (RTOG) Scales at 1, 4, 8 and 12 weeks from day 1 of treatment
6. Quality of life is measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-30) questionnaire at 1, 4, 8 and 12 weeks from day 1 of treatment compared to randomisation. This is either posted to the patient from UCT CTC or administered by the hospital trial team if the patient is an inpatient.
7. Further treatment is recorded using through phone interviews with the patient or where this is not possible, reviewing the patient notes, at 1, 4, 8 and 12 weeks and 12 months from day 1 of treatment
8. Duration of care in hospital, hospice, nursing home or home is determined through phone interviews with the patient or where this is not possible, reviewing the patient notes at 1, 4, 8 and 12 weeks
9. Preferred place of care is determined through phone interviews with the patient at 1, 4, 8 and 12 weeks from day 1 of treatment
10. Overall survival is determined at 12 and 52 weeks through review of patient notes. Alternatively the trial is flagged with the UK Health & Social Care Information Centre for survival data
Overall trial start date
01/09/2009
Overall trial end date
30/04/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Inclusion criteria as of 04/02/2016:
1. Decision to treat made no more than 48 hours prior to treatment of spinal cord or cauda equina (C1 to S2) compression, based on a full spinal MRI or CT scan confirming compression carried out no more than one week prior to treatment
2. Single site of compression or multiple sites that can be treated within a single radiation treatment field
3. Histologically or cytologically confirmed malignant disease, or for prostate tumours a serum PSA >100 ng/ml at any point prior to randomisation (if biopsy done or planned but results not yet available patients may be entered provided all other inclusion and exclusion criteria are met. Biopsy results must be submitted on the relevant CRF page as soon as they are available)
4. Life expectancy greater than 8 weeks
5. Age greater than or equal to 18 years, either sex
6. Able to give informed consent
7. Willing and able to complete assessment forms
Original inclusion criteria:
1. Proven diagnosis of spinal cord compression on magnetic resonance imaging (MRI) or computed tomography (CT) scan
2. Single site of compression or multiple sites that can be treated within a single radiation treatment field
3. Histologically or cytologically confirmed malignant disease, or for prostate tumours serum prostate specific antigen (PSA) at diagnosis of greater than 100 ng/ml
4. Life expectancy greater than 8 weeks
5. Age greater than or equal to 18 years, either sex
6. Able to give informed consent
7. Willing and able to complete assessment forms
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
700
Total final enrolment
686
Participant exclusion criteria
Exclusion criteria as of 04/02/2016:
1. Patients for whom surgery or chemotherapy treatment is more appropriate
2. Patients with multiple myeloma, lymphoma, leukaemia or glioma
3. Patients who are known to be pregnant
4. Patients undergoing purely prophylactic treatment in the absence of radiological spinal cord or cauda equina compression
5. Patients whose spinal compression site has been treated previously with radiotherapy
Original exclusion criteria:
1. Patients for whom surgery or chemotherapy treatment is more appropriate
2. Patients with multiple myeloma or lymphoma
3. Patients who are known to be pregnant
4. Patients undergoing purely prophylactic treatment for early onset spinal cord compression
5. Patients undergoing treatment for compression affecting the spinal canal below L1
Recruitment start date
01/09/2009
Recruitment end date
30/04/2016
Locations
Countries of recruitment
Australia, United Kingdom
Trial participating centre
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
Trial participating centre
Mater Health Services
Raymond Terrace
Brisbane
QLD 4101
Australia
Sponsor information
Organisation
University College London (UCL) (UK)
Sponsor details
c/o Nick McNally
Divisional Manager
Joint UCLH and UCL Biomedical Research Unit (1st Floor
Maple House)
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 5DB
United Kingdom
+44 (0)20 7380 9825
ctc.scorad@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C2422/A11408)
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
Available on request
Basic results (scientific)
Publication list
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31794625 (added 04/12/2019)