Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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