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 number NCT00727584
Secondary identifying numbers BRD/07/010
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

Study designRandomized controlled feasibility study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression
Study acronymSCORAD feasibility study
Study objectivesTo 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) studiedMetastatic spinal cord compression
InterventionRadiotherapy (single or multiple fractions):
Arm 1: 20 Gy/5 fractions daily for 5 consecutive days
Arm 2: 8 Gy/1 fraction
Intervention typeOther
Primary outcome measurePatient accrual per centre over a 12-month period.
Secondary outcome measures1. 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 date01/03/2008
Completion date31/08/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Total final enrolment686
Key inclusion criteria1. 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 criteria1. Patients for whom surgery or chemotherapy treatment is more appropriate
2. Patient known to be pregnant
Date of first enrolment01/03/2008
Date of final enrolment31/08/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Mount Vernon Hospital
Northwood
HA6 2RN
United Kingdom

Sponsor information

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

Medical School Administration
Gower Street
London
WC1E 6BT
England
United Kingdom

Website http://www.ucl.ac.uk/cancertrials/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C2422/A7932)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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

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