| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN97555949 |
| Date ISRCTN assigned | 23/07/2007 |
| Local reference number(s) | BRD/07/010 |
| 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 |
| Disease/condition/study domain | Metastatic spinal cord compression |
| 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. |
| Design/methodology | A randomised controlled feasibility study. |
| Research ethics review | To be submitted as of 04/06/2007. |
| Countries of trial | United Kingdom |
| 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 > 1 month
4. Age 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 who are known to be pregnant |
| Patient information material |
|
| Anticipated start date | 11/11/2007 |
| Anticipated end date | 11/11/2008 |
| Status of trial | Ongoing |
| 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 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 (ref: C2422/A7932) |
| Sponsor name | University College London (UK) |
| Sponsor details | Medical School Administration
Gower Street
London
United Kingdom
WC1E 6BT |
| Sponsor website | http://www.ucl.ac.uk/cancertrials/ |
| Contact name | Prof Peter J Hoskin |
| Contact details | Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
Northwood
United Kingdom
HA6 2RN |
| Contact telephone | +44 (0)1923 844533 |
| Contact fax | +44 (0)1923 844167 |
| Contact email | peterhoskin@nhs.net |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN97555949 |
| Date last extracted from ISRCTN register | 17/04/2008 |
