Metastatic spinal cord compression Cancer Malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system
Conditions
Interventions
Patient randomisation is performed using a 24 hour remote internet based randomisation programme.
Arm 1: External beam multi-fraction radiotherapy: 20Gy/5f
Arm 2: External beam single fraction radio
Sponsors
University College London (UCL) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 04/02/2016: 1. Decision to treat made no more than 48 hours prior to treatment of spinal cord or cauda equina (C1 to S2) compression, based on a full spinal MRI or CT scan confirming compression carried out no more than one week prior to treatment 2. Single site of compression or multiple sites that can be treated within a single radiation treatment field 3. Histologically or cytologically confirmed malignant disease, or for prostate tumours a serum PSA >100 ng/ml at any point prior to randomisation (if biopsy done or planned but results not yet available patients may be entered provided all other inclusion and exclusion criteria are met. Biopsy results must be submitted on the relevant CRF page as soon as they are available) 4. Life expectancy greater than 8 weeks 5. Age greater than or equal to 18 years, either sex 6. Able to give informed consent 7. Willing and able to complete assessment forms Original inclusion criteria: 1. Proven diagnosis of spinal cord compression on magnetic resonance imaging (MRI) or computed tomography (CT) scan 2. Single site of compression or multiple sites that can be treated within a single radiation treatment field 3. Histologically or cytologically confirmed malignant disease, or for prostate tumours serum prostate specific antigen (PSA) at diagnosis of greater than 100 ng/ml 4. Life expectancy greater than 8 weeks 5. Age greater than or equal to 18 years, either sex 6. Able to give informed consent 7. Willing and able to complete assessment forms
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 04/02/2016: 1. Patients for whom surgery or chemotherapy treatment is more appropriate 2. Patients with multiple myeloma, lymphoma, leukaemia or glioma 3. Patients who are known to be pregnant 4. Patients undergoing purely prophylactic treatment in the absence of radiological spinal cord or cauda equina compression 5. Patients whose spinal compression site has been treated previously with radiotherapy Original exclusion criteria: 1. Patients for whom surgery or chemotherapy treatment is more appropriate 2. Patients with multiple myeloma or lymphoma 3. Patients who are known to be pregnant 4. Patients undergoing purely prophylactic treatment for early onset spinal cord compression 5. Patients undergoing treatment for compression affecting the spinal canal below L1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ambulatory status is determined through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at 8 weeks from day 1 of treatment compared to randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recovery of and time to ambulation is measured through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at weeks 1, 4, 8, and 12 from day 1 of treatment compared to randomisation 2. Ambulatory status is determined using measured through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at 1, 4, and 12 weeks (where available) compared to randomisation 3. Maintenance of ambulatory status is determined through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at weeks 1, 4, 8, and 12 from day 1 of treatment compared to randomisation 4. Bladder and bowel function is measured through phone interviews with the patient or where this is not possible, reviewing the patient notes, at 1, 4, 8 and 12 weeks from day 1 of treatment compared to randomisation 5. Acute side effects are measured using through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying the Common Terminology Criteria for Adverse Events (CTCAE) scales v4.02 or Radiation Treatment and Oncology Groups (RTOG) Scales at 1, 4, 8 and 12 weeks from day 1 of treatment 6. Quality of life is measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-30) questionnaire at 1, 4, 8 and 12 weeks from day 1 of treatment compared to randomisation. This is either posted to the patient from UCT CTC or administered by the hospital trial team if the patient is an inpatient. 7. Further treatment is recorded using through phone interviews with the patient or where this is not possible, reviewing the patient notes, at 1, 4, 8 and 12 weeks and 12 months from day 1 of treatment 8. Duration of care in hospital, hospice, nursing home or home is det | — |
Countries
Australia, England, United Kingdom
Outcome results
None listed