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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
100
Patients undergo external beam radiotherapy
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Cancer Research UK and University College London Cancer Trials Centre
Northwood, England, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Christie Hospital
Manchester, United Kingdom
Patient accrual per center over a 12-month period
Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
Quality of life as measured by the EORTC QLQ-C30 questionnaire at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Further treatment
Overall survival at 3, 6, and 12 months
Total number of days spent in hospital
Preferred place of care
Number of patients eligible but not randomized and reasons for non-randomization
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