Status:
COMPLETED
Spinal Cord Compression. ICORG 05-03, V6
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Spinal Cord Compression
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 compres...
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....
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00968643
Start Date
January 1 2006
Last Update
December 31 2014
Active Locations (4)
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1
Cork University Hospital
Cork, Ireland
2
Saint Luke's Radiation Oncology Network (SLRON)
Dublin, Ireland, 6
3
Galway University Hospital
Galway, Ireland
4
Whitfield Cancer Centre at Whitfield Clinic
Waterford, Ireland