Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
126 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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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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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (control)
Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
radiation therapy
Given in multiple fractions or as a single fraction
Arm II
Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
radiation therapy
Given in multiple fractions or as a single fraction
Interventions
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radiation therapy
Given in multiple fractions or as a single fraction
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cancer Trials Ireland
NETWORK
Responsible Party
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Principal Investigators
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Pierre Thirion
Role: PRINCIPAL_INVESTIGATOR
St Luke's Radiation Oncology Network
Locations
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Cork University Hospital
Cork, , Ireland
Saint Luke's Radiation Oncology Network (SLRON)
Dublin, , Ireland
Galway University Hospital
Galway, , Ireland
Whitfield Cancer Centre at Whitfield Clinic
Waterford, , Ireland
Countries
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References
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Thirion PG, Dunne MT, Kelly PJ, Flavin A, O'Sullivan JM, Hacking D, Sasiadek W, Small C, Pomeroy MM, Martin J, McArdle O, Parker I, O'Sullivan LS, Shannon AM, Clayton-Lea A, Collins CD, Stevenson MR, Alvarez-Iglesias A, Armstrong JG, Moriarty M. Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression. Br J Cancer. 2020 Apr;122(9):1315-1323. doi: 10.1038/s41416-020-0768-z. Epub 2020 Mar 11.
Other Identifiers
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ICORG-05-03
Identifier Type: -
Identifier Source: secondary_id
EU-20952
Identifier Type: -
Identifier Source: secondary_id
05-03 ICORG
Identifier Type: -
Identifier Source: org_study_id