A Phase 3 interventional study of radiation therapy in Spinal Cord Compression and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Cancer Trials Ireland. Completed at 4 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-31.
Sponsored by Cancer Trials Ireland · Phase 3, Interventional, and Treatment
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
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
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.
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, excluding the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
Radiation: radiation therapy
Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
Radiation: radiation therapy
Given in multiple fractions or as a single fraction
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
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Cancer Trials Ireland