A Phase 2 interventional study of Cumulative BED ≤ 100 and Cumulative BED ≤ 130 Gy2 in Pain, Radiation Toxicity and Spinal Cord Compression, sponsored by Cancer Trials Ireland. Completed at 2 sites in Ireland. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-07-29.
Sponsored by Cancer Trials Ireland · Phase 2, Interventional, and Treatment
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 22 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Cancer Trials Ireland is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
MRI-confirmed diagnosis of malignant spinal cord compression
proven
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiation Cumulative BED ≤ 100 Gy2
Radiation: Cumulative BED ≤ 100
Cumulative BED ≤ 130 Gy2
Radiation: Cumulative BED ≤ 130 Gy2
Radiation
Radiation
Response to treatment as assessed by mobility via the Tomita mobility scale
Time frame: 5 weeks after completion of radiation therapy
Overall response rate (stabilization and response) (stage I)
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system
Time frame: 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
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Pain control via the pain visual analogue score
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Median survival (time from the date of recruitment/treatment to death)
Time frame: Until death
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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