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| ID | Type | Description | Link |
|---|---|---|---|
| CRUK-UCL-BRD-07-010 | |||
| CRUK-SCORAD | |||
| ISRCTN97555949 | |||
| EU-20863 |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression.
PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease [spinal metastases only vs spinal and non-bony metastases]). Patients are randomized to 1 of 2 treatment arms.
Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (multi-fraction radiotherapy) | Active Comparator | Patients undergo 5 fractions of 20 Gy external-beam radiotherapy. |
|
| Arm II (single-fraction radiotherapy) | Experimental | Patients undergo 1 fraction of 8 Gy external beam radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation | Patients undergo external beam radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient accrual per center over a 12-month period |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline | ||
| Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline | ||
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant disease
Proven diagnosis of metastatic spinal cord compression on MRI or CT scan
No patient for whom surgery or chemotherapy treatment is more appropriate
No multiple myeloma as primary cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J. Hoskin, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Haematology and Oncology Centre | Bristol | England | BS2 8ED | United Kingdom | ||
| Cancer Research UK and University College London Cancer Trials Centre |
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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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| Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment |
| Quality of life as measured by the EORTC QLQ-C30 questionnaire at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline |
| Further treatment |
| Overall survival at 3, 6, and 12 months |
| Total number of days spent in hospital |
| Preferred place of care |
| Number of patients eligible but not randomized and reasons for non-randomization |
| Northwood |
| England |
| HA6 2RN |
| United Kingdom |
| Glan Clwyd Hospital | Rhyl, Denbighshire | Wales | LL 18 5UJ | United Kingdom |
| Christie Hospital | Manchester | M20 6UX | United Kingdom |
| D014947 | Wounds and Injuries |