Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
spinal cord compression, unspecified adult solid tumor, protocol specific
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.
Interventions
RADIATIONradiation therapy
Patients undergo external beam radiotherapy
Sponsors
Cancer Research UK
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient accrual per center over a 12-month period | — |
Secondary
| Measure | Time frame |
|---|---|
| Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline | — |
| 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 | — |
| Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline | — |
| Total number of days spent in hospital | — |
| Preferred place of care | — |
| Number of patients eligible but not randomized and reasons for non-randomization | — |
| Overall survival at 3, 6, and 12 months | — |
Countries
United Kingdom
Outcome results
None listed