A Phase 3 interventional study of radiation therapy in Spinal Cord Compression and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Cancer Trials Ireland. Completed at 4 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-31.
Sponsored by Cancer Trials Ireland · Phase 3, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression.
PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
Patients complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, at 5 weeks, and then every 3 months thereafter.
After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.
52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.
This study's planned enrollment of 126 is above the median of 43 across 35 interventional studies indexed under Spinal Cord Compression.
Browse Spinal Cord Compression 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:
confirmed , excluding the following:
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
Radiation: radiation therapy
Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
Radiation: radiation therapy
Given in multiple fractions or as a single fraction
Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
Time frame: 5 weeks from date of randomisation
Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire
Time frame: 5 weeks from date of randomisation
Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale
Time frame: 1 week after completion of therapy
Pain control: assessed using a Visual Analogue Scale
Time frame: Until death
Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause
Time frame: Until death
Sphincter function: assessed using an 'In-House' Bladder Function Scale
Time frame: Until death
The record gives a start of Jan 2006 and a primary completion of May 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Cancer Trials Ireland