RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may be effective in treating malignant spinal cord compression in patients who have received previous radiation therapy to the spine. PURPOSE: This phase II trial is studying radiation therapy in treating patients with malignant spinal cord compression.
OBJECTIVES: Primary * To determine the efficacy of a biologically effective dose-based re-irradiation strategy, in terms of the response rate (based on the mobility score using the Tomita scale where improvement in mobility or stable mobility score will be regarded as a response) in patients with malignant spinal cord compression. Secondary * To determine quality of life as assessed by the EORTC QLQ-C15 PAL version 1.0 questionnaire. * To determine the non-spinal radiation-induced toxicity using standard RTOG criteria. * To determine the rate of long-term spinal toxicity and radiation-induced myelopathy using the RTOG SOMA morbidity grading system. OUTLINE: Patients are divided into 2 groups according to the interval since their most recent radiotherapy to the involved area of the spinal cord. * Group 1 (\< 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative biologically effective dose (BED) ≤ 100 Gy\_2 in addition to receiving other current treatment. * Group 2 (≥ 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative BED ≤ 130 Gy\_2 in addition to receiving other current treatment. Mobility score is assessed and patients complete a quality-of-life assessment at baseline and at each follow-up visit starting at week 5. After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Radiation
Radiation
Saint Luke's Radiation Oncology Network
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Response to treatment as assessed by mobility via the Tomita mobility scale
Time frame: 5 weeks after completion of radiation therapy
Overall response rate (stabilization and response) (stage I)
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Toxicity other than spine (acute toxicity assessed at weeks 1 and 5 and late toxicity assessed at 3 months and at subsequent follow-ups) evaluated according to RTOG criteria
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Pain control via the pain visual analogue score
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Median survival (time from the date of recruitment/treatment to death)
Time frame: Until death
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