Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
Verified date | June 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignant disease - Proven diagnosis of metastatic spinal cord compression on MRI or CT scan - Single site of compression OR multiple sites that can be treated within a single radiation treatment field - No patient for whom surgery or chemotherapy treatment is more appropriate - No multiple myeloma as primary cancer PATIENT CHARACTERISTICS: - Life expectancy > 1 month - Not pregnant - Willing and able to complete assessment forms - Able to give informed consent PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Bristol Haematology and Oncology Centre | Bristol | England |
United Kingdom | Christie Hospital | Manchester | |
United Kingdom | Cancer Research UK and University College London Cancer Trials Centre | Northwood | England |
United Kingdom | Glan Clwyd Hospital | Rhyl, Denbighshire | Wales |
Lead Sponsor | Collaborator |
---|---|
Cancer Research UK |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient accrual per center over a 12-month period | No | ||
Secondary | Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline | No | ||
Secondary | Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline | Yes | ||
Secondary | Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment | Yes | ||
Secondary | 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 | No | ||
Secondary | Further treatment | No | ||
Secondary | Overall survival at 3, 6, and 12 months | No | ||
Secondary | Total number of days spent in hospital | No | ||
Secondary | Preferred place of care | No | ||
Secondary | Number of patients eligible but not randomized and reasons for non-randomization | No |
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