Skip to main content
. 2015 Sep 4;2015(9):CD006716. doi: 10.1002/14651858.CD006716.pub3

Young 1980.

Methods Randomised, parallel group, two arm, active controlled, open label, two‐centre trial
Participants Inclusion:
tissue diagnosis of a malignant tumour not of central nervous system origin; the presence of clinical symptoms of cord compression; and a myelogram showing extradural lesion or block that correlated with clinical presentation
 Exclusion:
prior radiotherapy, unfit for surgery, more than one lesion, presence of only spinal or radicular pain.
 Age: 19 to 83 years
 Gender: not stated
 Pretreatment ambulant: laminectomy plus radiotherapy versus radiotherapy alone: 6 versus 5
 Performance status: not stated
 Type of primary tumours: all types
 Visceral metastasis: not stated
 Duration and rapidity of cord compression: not stated
 Spinal level: not stated
 Spinal instability: not stated
Interventions Intervention
laminectomy with radiotherapy: 30 Gy in 10 fractions over 14 days + steroids* (N = 16)
 Control
radiotherapy: 30 Gy in 10 fractions (4 Gy/day first 3 days, then 18 Gy in 7 fractions over 14 days) + steroids* (N = 13)
Timing of intervention in relation to development of cord compression ‐ not stated
 Concomitant medications: *Dexamethasone 12 mg stat followed by 4 mg four times daily till radiotherapy completion; other medications ‐not reported
Outcomes Outcomes reported and used:
  1. Ambulation (ability to take steps alone with or without a cane or walker at four months): overall ambulatory rates, proportion maintaining ambulation and proportion regaining ambulation

  2. Survival

  3. Pain relief: Reduction in analgesic use

  4. Urinary continence: overall, proportion maintaining and regaining continence

  5. Adverse effects


Outcomes reported but not used:
  1. Mean survival (no SD)


Outcomes sought but not reported:
  1. Local recurrence

  2. Quality of life,

  3. Participant and caregiver satisfaction,

  4. Characteristics of patients who benefit the treatment

Notes Setting: two centres in USA
Period of study: not reported
Provision for rehabilitation: not reported
Source of funding: not reported
Comments:
radiotherapy alone: mortality ‐ 24% (due to underlying disease)
duration of follow‐up: participants were followed up at regular intervals until death; duration unclear
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was carried out using a "table of random numbers"
Allocation concealment (selection bias) High risk Not stated; there were also baseline imbalances in prognostic variables that might have occurred due to lack of stratification
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Lack of blinding could have led to differential interventions in terms of pain medication; though no differences were noted with interventions
Blinding of outcome assessment (detection bias) 
 Objective outcomes Low risk Ambulatory status was clearly defined and minimised the possibility of observer bias
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk While subjective outcomes were operationally defined, detection bias cannot be ruled out in this open label trial
Incomplete outcome data (attrition bias) 
 Efficacy outcomes Low risk There was no attrition
Incomplete outcome data (attrition bias) 
 Adverse events Low risk As above
Selective reporting (reporting bias) Low risk The trial protocol was not available but all relevant outcomes were reported
Other bias Low risk No other sources of bias were identified

MRI ‐ magnetic resonance imaging
 CT‐ computed tomography
 ECOG ‐ Eastern Co‐operative Oncology Group
 SD ‐ standard deviation
 Gy ‐ Gray