Single fraction versus multifraction radiotherapy for patients with metastatic spinal cord compression

ISRCTN	ISRCTN97108008
DOI	https://doi.org/10.1186/ISRCTN97108008
ClinicalTrials.gov number	NCT00727584
Secondary identifying numbers	N/A

Submission date: 12/05/2009
Registration date: 26/06/2009
Last edited: 07/05/2024

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-single-radiotherapy-treatment-with-course-of-radiotherapy-treatments-cancer-pressing-on-spinal-cord-SCORAD-III

Study website

Contact information

Prof Peter Hoskin
Scientific

Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
HA6 2RN
United Kingdom

Phone	+44 1923 844 533
Email	ctc.scorad@ucl.ac.uk

Study information

Study design	Multicentre randomized phase III trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Can be found at: http://www.ucl.ac.uk/cancertrials/trials/scorad/SCORAD%20summary%20April%2007.pdf
Scientific title	A randomised phase III trial of single fraction radiotherapy compared to multifraction radiotherapy in patients with metastatic spinal cord compression
Study acronym	SCORAD III
Study objectives	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(s)	North West London REC 1, 03/11/2009, ref: 09/H0722/76
Health condition(s) or problem(s) studied	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
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 study start date	01/09/2009
Completion date	30/04/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	700
Total final enrolment	686
Key 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
Key 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
Date of first enrolment	01/09/2009
Date of final enrolment	30/04/2016

Locations

Countries of recruitment

Australia
England
United Kingdom

Study participating centres

Cancer Research UK & UCL Cancer Trials Centre

University College London
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Mater Health Services

Raymond Terrace
Brisbane
QLD 4101
Australia

Sponsor information

University College London (UCL) (UK)
University/education

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
England
United Kingdom

Phone	+44 (0)20 7380 9825
Email	ctc.scorad@ucl.ac.uk
Website	http://www.ucl.ac.uk/jro
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C2422/A11408)
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	Yes
IPD sharing plan summary	Available on request
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?
Protocol file		03/03/2013		No	No
Results article	results	03/12/2019	04/12/2019	Yes	No
Plain English results			01/06/2023	No	Yes
Results article	Quality-of-life outcomes	05/05/2024	07/05/2024	Yes	No

Additional files

18730_PROTOCOL_03Mar2013.pdf

Editorial Notes

07/05/2024: Publication reference added.
01/06/2023: Plain English results link added.
04/12/2019: Publication reference and total final enrolment number added.
26/02/2019: Uploaded protocol V4.0 03/03/2013 (not peer reviewed).
22/03/2016: The Australian trial participating centre (Mater centre) has been added, as well as the methods of measurement used to measure each of the outcome measures. In addition, the availability of the participant level data has been added.
04/02/2016: The overall trial end date has been updated from 01/09/2014 to 30/04/2017 and the recruitment end date has been updated from 14/07/2015 to 30/04/2016. In addition, the inclusion and exclusion criteria have been updated and the trial participating centre has been changed from the Marie Curie Research Wing to Cancer Research UK & UCL Cancer Trials Centre.
01/03/2011: The overall trial end date was changed from 01/09/2014 to 14/07/2015.