Radiation Therapy in Treating Patients With Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy. ICORG 07-11
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.
|Pain Radiation Toxicity Spinal Cord Compression Unspecified Adult Solid Tumor, Protocol Specific||Radiation: Cumulative BED ≤ 100 Radiation: Cumulative BED ≤ 130 Gy2||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression|
- 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 ]
|Study Start Date:||October 2007|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: A
Radiation Cumulative BED ≤ 100 Gy2
Radiation: Cumulative BED ≤ 100
Active Comparator: B
Cumulative BED ≤ 130 Gy2
Radiation: Cumulative BED ≤ 130 Gy2
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974168
|Saint Luke's Radiation Oncology Network|
|Dublin, Ireland, 6|
|Galway University Hospital|
|Principal Investigator:||Pierre Thirion, MD||Saint Luke's Hospital|