NCT00968643

Spinal Cord Compression. ICORG 05-03, V6

A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Cancer Trials Ireland · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
RADIATION	radiation therapy	Given in multiple fractions or as a single fraction

Timeline

• Start date: 2006-01-01
• Primary completion: 2014-05-01
• First posted: 2009-08-31
• Last updated: 2014-12-31

Locations

4 sites across 1 country: Ireland