A randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression
ISRCTN | ISRCTN97555949 |
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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
Plain English summary of protocol
Contact information
Scientific
Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
Northwood
HA6 2RN
United Kingdom
Phone | +44 (0)1923 844533 |
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peterhoskin@nhs.net |
Study information
Study design | Randomized controlled feasibility study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/03/2008 |
Completion date | 31/08/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
HA6 2RN
United Kingdom
Sponsor information
University/education
Medical School Administration
Gower Street
London
WC1E 6BT
England
United Kingdom
Website | http://www.ucl.ac.uk/cancertrials/ |
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https://ror.org/02jx3x895 |
Funders
Funder type
Charity
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
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 |
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