Single fraction versus multifraction radiotherapy for patients with metastatic spinal cord compression
ISRCTN | ISRCTN97108008 |
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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
Plain English summary of protocol
Contact information
Scientific
Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
HA6 2RN
United Kingdom
Phone | +44 1923 844 533 |
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ctc.scorad@ucl.ac.uk |
Study information
Study design | Multicentre randomized phase III trial |
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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 |
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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
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
Brisbane
QLD 4101
Australia
Sponsor information
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 |
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ctc.scorad@ucl.ac.uk | |
Website | http://www.ucl.ac.uk/jro |
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 | 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
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.