| ID | Type | Description | Link |
|---|---|---|---|
| ICORG 07-11 | |||
| EU-20953 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are divided into 2 groups according to the interval since their most recent radiotherapy to the involved area of the spinal cord.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Radiation Cumulative BED ≤ 100 Gy2 |
|
| B | Active Comparator | Cumulative BED ≤ 130 Gy2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cumulative BED ≤ 100 | Radiation | Radiation |
| |
| Cumulative BED ≤ 130 Gy2 |
| 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 |
| 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 |
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DISEASE CHARACTERISTICS:
MRI-confirmed diagnosis of malignant spinal cord compression
Histologically proven malignancy
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)
Deemed not suitable for neurosurgical intervention at the time of initial assessment
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Thirion, Dr | Saint Luke's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Radiation Oncology Network | Dublin | 6 | Ireland | |||
| Galway University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36482188 | Derived | Wallace ND, Dunne MT, McArdle O, Small C, Parker I, Shannon AM, Clayton-Lea A, Parker M, Collins CD, Armstrong JG, Gillham C, Coffey J, Fitzpatrick D, Salib O, Moriarty M, Stevenson MR, Alvarez-Iglesias A, McCague M, Thirion PG. Efficacy and toxicity of primary re-irradiation for malignant spinal cord compression based on radiobiological modelling: a phase II clinical trial. Br J Cancer. 2023 Feb;128(4):576-585. doi: 10.1038/s41416-022-02078-w. Epub 2022 Dec 8. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D011832 | Radiation Injuries |
| D013117 | Spinal Cord Compression |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| Radiation |
Radiation |
|
| 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 |
| Galway |
| Ireland |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013119 | Spinal Cord Injuries |