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| ID | Type | Description | Link |
|---|---|---|---|
| ICORG-05-03 | |||
| EU-20952 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (control) | Active Comparator | Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy). |
|
| Arm II | Experimental | Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation | Given in multiple fractions or as a single fraction |
|
| 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 |
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, excluding the following:
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Thirion | St Luke's Radiation Oncology Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork University Hospital | Cork | Ireland | ||||
| Saint Luke's Radiation Oncology Network (SLRON) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32157242 | Derived | 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. |
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| ID | Term |
|---|---|
| D013117 | Spinal Cord Compression |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013119 | Spinal Cord Injuries |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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 |
| Dublin |
| 6 |
| Ireland |
| Galway University Hospital | Galway | Ireland |
| Whitfield Cancer Centre at Whitfield Clinic | Waterford | Ireland |
| D014947 | Wounds and Injuries |