A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Yes
Pierre Thirion
Principal Investigator
St Luke's Radiation Oncology Network
Ireland: Irish Medicines Board
CDR0000644307
NCT00968643
January 2006
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