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| [ Print-friendly version ] |
| A randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression |
| ISRCTN | ISRCTN97555949 |
| ClinicalTrials.gov identifier | NCT00727584 |
| Public title | A randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression |
| Scientific title | |
| Acronym | SCORAD feasibility study |
| Serial number at source | BRD/07/010 |
| Study hypothesis |
To examine whether a phase III randomised trial comparing a single fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and patients.
As of 29/04/2008 the anticipated start and end dates of this trial were updated. The initial anticipated start and end dates of this trial were: Anticipated start date: 11/11/2007 Anticipated end date: 11/11/2008 As of 12/05/2009 the anticipated end date of this trial was again extended; the previous anticipated end date was 21/02/2009. |
| Ethics approval | Cornwall and Plymouth Research Ethics Committee approved before patient recruitment began (ref: 07/H0203/167) |
| Study design | Randomised controlled feasibility study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Metastatic spinal cord compression |
| Participants - 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 |
| Participants - exclusion criteria |
1. Patients for whom surgery or chemotherapy treatment is more appropriate
2. Patient known to be pregnant |
| Anticipated start date | 01/03/2008 |
| Anticipated end date | 31/08/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 100 |
| Interventions |
Radiotherapy (single or multiple fractions):
Arm 1: 20 Gy/5 fractions daily for 5 consecutive days Arm 2: 8 Gy/1 fraction |
| Primary outcome measure(s) | Patient accrual per centre over a 12-month period. |
| 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 |
| Sources of funding | Cancer Research UK (CRUK) (UK) (ref: C2422/A7932) |
| Trial website | |
| Publications | |
| Contact name | Prof Peter J Hoskin |
| Address |
Marie Curie Research Wing
Mount Vernon Hospital Rickmansworth Road Northwood Middlesex |
| City/town | Northwood |
| Zip/Postcode | HA6 2RN |
| Country | United Kingdom |
| Tel | +44 (0)1923 844533 |
| Fax | +44 (0)1923 844167 |
| peterhoskin@nhs.net | |
| Sponsor | University College London (UCL) (UK) |
| Address |
Medical School Administration
Gower Street |
| City/town | London |
| Zip/Postcode | WC1E 6BT |
| Country | United Kingdom |
| Sponsor website: | http://www.ucl.ac.uk/cancertrials/ |
| Date applied | 04/06/2007 |
| Last edited | 12/05/2009 |
| Date ISRCTN assigned | 23/07/2007 |
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