A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression
- 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
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to treatment as assessed by mobility via the Tomita mobility scale
5 weeks after completion of radiation therapy
Pierre Thirion, MD
Saint Luke's Hospital
Ireland: Irish Medicines Board