Erythropoietin Spinal Cord Compression Randomized Trial
Nerve Compression Syndromes
About this trial
This is an interventional treatment trial for Nerve Compression Syndromes focused on measuring Malignant extradural spinal cord compression, Erythropoietin, Neuroprotectant, Radiotherapy, Palliation
Eligibility Criteria
Inclusion Criteria: Adults (> 18 years old) with histopathologically confirmed cancer Patients unable to ambulate independently due to paraparesis or paraplegia from malignant epidural spinal cord compression (categories 2, 3, 4 in Appendix B) Radiotherapy offered for treatment of cord compression using 2000cGy in 5 fractions Informed consent signed Females subjects must be post-menopausal or surgically incapable of childbearing potential, must be practicing an acceptable method of birth control (i.e., hormonal contraceptives, intrauterine device or barrier and spermicide) Exclusion Criteria: Uncontrolled hypertension (systolic pressure > 160 mmHg, diastolic > 100 mmHg) or unstable cardiovascular disease Previous DVT/PE or arterial embolic event Patients with a Hb > 120 g/L or Hct > 40% (for both males & females) Patients with potentially curable disease Patients with life expectancy < 3 months Patients who have received RT that would overlap with the planned treatment field Contraindications for MRI scan Women who are pregnant, or who intend to become pregnant, or who are nursing Patients with known brain metastases; those with a primary diagnosis of melanoma will require confirmation by CT or MRI Patients with a history of poorly controlled seizure disorder Patients with a known hypersensitivity to mammalian cell-derived products or albumin Patients who cannot receive adequate antithrombotic treatment, who have a hypersensitivity to the active antithrombotic substance or any of the product's excipients Patients who have participated in another investigational device or drug trial(s), or is receiving other investigational agent(s) within the previous 30 days Patients requiring neurosurgical decompression for the malignant spinal cord compression
Sites / Locations
- London Regional Health Science Center
- Ottawa Regional Cancer Center
- Sunnybrook & Women's College Health Science Centre