A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Overall response rate (stabilization and response) (stage I)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall response rate (stabilization and response) (stage I)
Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Response to treatment as assessed by mobility via the Tomita mobility scale
Time Frame: 5 weeks after completion of radiation therapy
Secondary Outcomes
- Pain control via the pain visual analogue score(5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter)
- Median survival (time from the date of recruitment/treatment to death)(Until death)
- Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system(5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter)
- 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)