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A randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression

A randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN97555949
Enrollment
100
Registered
2007-07-23
Start date
2008-03-01
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic spinal cord compression Cancer Malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system

Interventions

Radiotherapy (single or multiple fractions): Arm 1: 20 Gy/5 fractions daily for 5 consecutive days Arm 2: 8 Gy/1 fraction

Sponsors

University College London (UCL) (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Patients for whom surgery or chemotherapy treatment is more appropriate 2. Patient known to be pregnant

Design outcomes

Primary

MeasureTime frame
Patient accrual per centre over a 12-month period.

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026