A randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression

ISRCTN	ISRCTN97555949
DOI	https://doi.org/10.1186/ISRCTN97555949
ClinicalTrials.gov (NCT)	NCT00727584
Protocol serial number	BRD/07/010
Sponsor	University College London (UCL) (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C2422/A7932)

Submission date: 04/06/2007
Registration date: 23/07/2007
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-study-comparing-a-single-radiotherapy-treatment-with-a-course-of-radiotherapy-treatments-for-cancer-pressing-on-the-spinal-cord

Contact information

Prof Peter J Hoskin
Scientific

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

Phone	+44 (0)1923 844533
Email	peterhoskin@nhs.net

Study information

Primary study design	Interventional
Study design	Randomized controlled feasibility study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression
Study acronym	SCORAD feasibility study
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	Patient accrual per centre over a 12-month period.
Key secondary outcome measure(s)	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
Completion date	31/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Total final enrolment	686
Key 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
Key exclusion criteria	1. Patients for whom surgery or chemotherapy treatment is more appropriate 2. Patient known to be pregnant
Date of first enrolment	01/03/2008
Date of final enrolment	31/08/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Mount Vernon Hospital

Northwood
HA6 2RN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	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
Results article	Quality-of-life outcomes	05/05/2024	07/05/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes

Editorial Notes

07/05/2024: Publication reference added.
25/10/2022: Cancer Research UK plain English results link added.
04/01/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
26/02/2019: No publications found. All search options exhausted.
11/10/2017: No publications found, verifying study status with principal investigator.
12/05/2009: The overall trial end date was changed from 21/02/2009 to 31/08/2009.
29/04/2008: The overall trial start and end dates were updated. The initial overall trial start and end dates were:
Overall trial start date: 11/11/2007
Overall trial end date: 11/11/2008