Pain, Radiation Toxicity, Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
pain, radiation toxicity, spinal cord compression, unspecified adult solid tumor, protocol specific
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONCumulative BED ≤ 100
Radiation
RADIATIONCumulative BED ≤ 130 Gy2
Radiation
Sponsors
Cancer Trials Ireland
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * MRI-confirmed diagnosis of malignant spinal cord compression * MRI of the entire spine performed * Histologically proven malignancy * No primary tumors of the spine or vertebral column * Undergone previous radiotherapy to the involved area of the spinal cord (e.g., full segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated) * Maximum biologically effective dose received from previous irradiation ≤ 90 Gy\_2 * Deemed not suitable for neurosurgical intervention at the time of initial assessment * Patients deemed inoperable are eligible PATIENT CHARACTERISTICS: * Karnofsky performance status 40-100% * Short life expectancy * No medical or psychiatric condition that, in the opinion of the investigator or research team, contraindicates participation in this study PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment as assessed by mobility via the Tomita mobility scale | 5 weeks after completion of radiation therapy |
| Overall response rate (stabilization and response) (stage I) | 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter |
Secondary
| Measure | Time frame |
|---|---|
| Pain control via the pain visual analogue score | 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter |
| Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system | 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter |
| Median survival (time from the date of recruitment/treatment to death) | Until death |
| Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire | 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 | 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter |
Countries
Ireland
Outcome results
None listed