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Brief Title: Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression
Official Title: SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
Study ID: NCT00727584
Brief Summary: 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.
Detailed Description: OBJECTIVES: * To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression. * To determine the feasibility of conducting this study in the United Kingdom. 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. * Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy. * Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Cancer Research UK and University College London Cancer Trials Centre, Northwood, England, United Kingdom
Glan Clwyd Hospital, Rhyl, Denbighshire, Wales, United Kingdom
Christie Hospital, Manchester, , United Kingdom
Name: Peter J. Hoskin, MD
Affiliation: Mount Vernon Cancer Centre at Mount Vernon Hospital
Role: PRINCIPAL_INVESTIGATOR