Spinal Cord Compression Re-Treat Study

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Radiation: Cumulative BED ≤ 100
* Radiation: Cumulative BED ≤ 130 Gy2


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: MRI-confirmed diagnosis of malignant spinal cord compression MRI of the entire spine performed Histologically proven malignancy No primary tumors of the spine or vertebral column Undergone previous radiotherapy to the involved area of the spinal cord (e.g., full segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated) Maximum biologically effective dose received from previous irradiation ≤ 90 Gy_2 Deemed not suitable for neurosurgical intervention at the time of initial assessment Patients deemed inoperable are eligible PATIENT CHARACTERISTICS: Karnofsky performance status 40-100% Short life expectancy No medical or psychiatric condition that, in the opinion of the investigator or research team, contraindicates participation in this study PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Radiation Cumulative BED ≤ 100 Gy2 | Radiation: Cumulative BED ≤ 100<br>* Radiation<br>|
| Active Comparator: B<br>Cumulative BED ≤ 130 Gy2 | Radiation: Cumulative BED ≤ 130 Gy2<br>* Radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment as assessed by mobility via the Tomita mobility scale |  | 5 weeks after completion of radiation therapy | 
| Overall response rate (stabilization and response) (stage I) |  | 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system |  | 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 | 
| Pain control via the pain visual analogue score |  | 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 | 
| Median survival (time from the date of recruitment/treatment to death) |  | Until death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, radiation toxicity, spinal cord compression, unspecified adult solid tumor, protocol specific