Spinal Cord Compression. ICORG 05-03, V6
- Conditions
- Unspecified Adult Solid Tumor, Protocol SpecificSpinal Cord Compression
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT00968643
- Lead Sponsor
- Cancer Trials Ireland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (control) radiation therapy Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy). Arm II radiation therapy Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
- Primary Outcome Measures
Name Time Method Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale 5 weeks from date of randomisation
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Cork University Hospital
🇮🇪Cork, Ireland
Galway University Hospital
🇮🇪Galway, Ireland
Whitfield Cancer Centre at Whitfield Clinic
🇮🇪Waterford, Ireland
Saint Luke's Radiation Oncology Network (SLRON)
🇮🇪Dublin, Ireland