Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet
known which radiation therapy regimen is more effective in treating metastatic spinal cord
compression.
PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see
how well they work in treating 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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