Trial Information

SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-Fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression

OBJECTIVES:

- To examine whether a phase III randomized study comparing a single-fraction of
radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to
patients with metastatic spinal cord compression.

- To determine the feasibility of conducting this study in the United Kingdom.

OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known
prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of
disease [spinal metastases only vs spinal and non-bony metastases]). Patients are randomized
to 1 of 2 treatment arms.

- Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy
external-beam radiotherapy.

- Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external
beam radiotherapy.

Patients undergo assessment of ambulatory status, quality of life, bladder and bowel
function, and acute toxicity via self-reported questionnaires and telephone follow-ups at
baseline and weeks 1, 4, 8, and 12.