Spinal Cord Compression. ICORG 05-03, V6

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Compression
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00968643
• Study type: Interventional
• Source: ICORG- All Ireland Cooperative Oncology Research Group
• Status: Completed
• Phase: Phase 3
• Start date: January 2006