- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Cork, Ireland
- Cork University Hospital
-
Dublin, Ireland, 6
- Saint Luke's Radiation Oncology Network (SLRON)
-
Galway, Ireland
- Galway University Hospital
-
Waterford, Ireland
- Whitfield Cancer Centre at Whitfield Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Arm I (control)
Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
|
Given in multiple fractions or as a single fraction
|
EXPERIMENTAL: Arm II
Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
|
Given in multiple fractions or as a single fraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
Time Frame: 5 weeks from date of randomisation
|
5 weeks from date of randomisation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire
Time Frame: 5 weeks from date of randomisation
|
5 weeks from date of randomisation
|
Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale
Time Frame: 1 week after completion of therapy
|
1 week after completion of therapy
|
Pain control: assessed using a Visual Analogue Scale
Time Frame: Until death
|
Until death
|
Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause
Time Frame: Until death
|
Until death
|
Sphincter function: assessed using an 'In-House' Bladder Function Scale
Time Frame: Until death
|
Until death
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre Thirion, St Luke's Radiation Oncology Network
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-03 ICORG
- ICORG-05-03
- EU-20952
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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