Pain Clinical Trial
Official title:
A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression
Verified date | July 2018 |
Source | Cancer Trials Ireland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | September 27, 2018 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Ireland | Saint Luke's Radiation Oncology Network | Dublin | |
Ireland | Galway University Hospital | Galway |
Lead Sponsor | Collaborator |
---|---|
Cancer Trials Ireland |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to treatment as assessed by mobility via the Tomita mobility scale | 5 weeks after completion of radiation therapy | ||
Primary | Overall response rate (stabilization and response) (stage I) | 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter | ||
Secondary | Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system | 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter | ||
Secondary | 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 | ||
Secondary | Pain control via the pain visual analogue score | 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter | ||
Secondary | Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire | 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter | ||
Secondary | Median survival (time from the date of recruitment/treatment to death) | Until death |
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