Spinal Cord Compression. ICORG 05-03, V6

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignancy, excluding the following: Leukemia Myeloma Germ cell tumor Primary tumor of the spine or vertebral column Diagnosis of malignant spinal cord compression confirmed by MRI of the entire spine Deemed inoperable or unsuitable for neurosurgical intervention at the time of initial assessment No single bone metastasis with controlled primary site PATIENT CHARACTERISTICS: Karnofsky performance status 30-100% No medical or psychiatric condition that, in the opinion of the investigator or research team, would contraindicate study participation PRIOR CONCURRENT THERAPY: No prior radiotherapy to the involved area of the spinal cord such that further treatment exceeds spinal cord tolerance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (control)<br>Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy). | Radiation: radiation therapy<br>* Given in multiple fractions or as a single fraction<br>|
| Experimental: Arm II<br>Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy). | Radiation: radiation therapy<br>* Given in multiple fractions or as a single fraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire |  | 5 weeks from date of randomisation | 
| Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale |  | 1 week after completion of therapy | 
| Pain control: assessed using a Visual Analogue Scale |  | Until death | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord compression, unspecified adult solid tumor, protocol specific