A randomised phase III trial of single fraction radiotherapy compared to multifraction radiotherapy in patients with metastatic spinal cord compression (SCC).
Description
Design:
SCORAD III was a multicentre, randomised phase III trial, stratified according to radiotherapy centre, ambulatory status, type of primary tumour and extent of disease (presence or absence of nonskeletal metastases).
Treatment:
Arm 1: Multiple fraction radiotherapy 20Gy/5f
Arm 2: Single fraction radiotherapy 8Gy/1f
Key inclusion/exclusion criteria:
Inclusions:
- Decision to treat made ≤48 hours before SCC treatment.
- Single compression site or multiple sites treated in one radiation field
- Malignant disease confirmed histologically or cytologically or a PSA >100 ng/ml at any point before randomisation (if biopsy done or planned but results not yet available patients may enter)
- Life expectancy >8 weeks
Exclusions:
- Surgery or chemotherapy more appropriate
- Multiple myeloma, lymphoma, leukaemia or glioma
- Prophylactic treatment with no radiological spinal cord or cauda equina compression
- Compression site has been treated previously with radiotherapy
Duration of recruitment:
6 Years (closed to recruitment 30 April 2016). 611 patients were randomised from 47 sites.
Aim
SCC is a common complication of metastatic cancer. The main treatment is radiotherapy, to preserve or recover neurological function and prevent further progression of symptoms. There is currently no standard fractionation schedule. The aim is to show that ambulatory status using 8Gy/1f is no worse than with 20Gy/5f for patients with SCC.
The primary endpoint is ambulatory status at 8 wks from treatment day 1, compared to randomisation.