NCT00974168

Spinal Cord Compression Re-Treat Study

A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Cancer Trials Ireland · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Radiation Toxicity
• Spinal Cord Compression
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
RADIATION	Cumulative BED ≤ 100	Radiation
RADIATION	Cumulative BED ≤ 130 Gy2	Radiation

Timeline

• Start date: 2007-10-01
• Primary completion: 2016-12-01
• Completion: 2018-09-27
• First posted: 2009-09-10
• Last updated: 2019-07-29

Locations

2 sites across 1 country: Ireland