A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Spinal Cord Compression
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 126
- Locations
- 4
- Primary Endpoint
- Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale(1 week after completion of therapy)
- Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire(5 weeks from date of randomisation)
- Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause(Until death)
- Sphincter function: assessed using an 'In-House' Bladder Function Scale(Until death)
- Pain control: assessed using a Visual Analogue Scale(Until death)