RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression. PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.
OBJECTIVES: Primary * To compare the response in patients with malignant spinal cord compression treated with single fraction (10 Gy) radiotherapy vs standard multiple fraction (20 Gy) radiotherapy. * To compare the toxicity of these treatment regimens in these patients. Secondary * Examine the safety, practicability, and efficacy of treatment with a single 10 Gy fraction of radiotherapy in these patients. * Analyze the initial neurological status, document the response to treatment, and calculate median survival of these patients. * Perform an economic impact analysis comparing the two treatment arms. OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I (control): Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy). * Arm II: Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy). Patients complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, at 5 weeks, and then every 3 months thereafter. After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Given in multiple fractions or as a single fraction
Cork University Hospital
Cork, Ireland
Saint Luke's Radiation Oncology Network (SLRON)
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Whitfield Cancer Centre at Whitfield Clinic
Waterford, Ireland
Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
Time frame: 5 weeks from date of randomisation
Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire
Time frame: 5 weeks from date of randomisation
Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale
Time frame: 1 week after completion of therapy
Pain control: assessed using a Visual Analogue Scale
Time frame: Until death
Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause
Time frame: Until death
Sphincter function: assessed using an 'In-House' Bladder Function Scale
Time frame: Until death
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