Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT00974168
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.
Study:
NCT00974168
Study Brief:
Protocol Section:
NCT00974168