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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2012 May 16;5:CD007583. doi: 10.1002/14651858.CD007583.pub3
Methods Multicentre RCT
Participants Country: German Democratic Republic
120 women with squamous cell carcinomas of the cervix uteri stage pT1bN0M0 previously treated by radical hysterectomy
The mean age at study entry was 40.6 years (range: 23 to 60 years)
All women presented with FIGO stage I.
Tumour cell type was squamous in all 120 (100%) women
Tumour grade: 1: 36 (30%), 2: 60 (50%), 3: 24 (20%)
Interventions Women were randomised into 2 groups:
  • Group A: women without further treatment (n = 60)

  • Group B: women received additional RT with 52-Gy tumour dose to the whole pelvis by external radiation with a cobault-60 unit. This was delivered at a rate or 2 Gy per day beginning 6 weeks after surgery (n = 60)

Outcomes
  • Number of deaths within 5 years (and time to death) were reported: HR was not reported and insufficient data were presented to allow estimation using Parmar 1998’s methods

  • Time to disease recurrence

  • Adverse events:
    • ○ gastrointestinal
    • ○ genitourinary
    • ○ lymphoedema
    • ○ rectal/sigmoid strictures
    • ○ hydronephrosis
Notes Mean length of follow-up was 44 months (range 24 to 72 months)
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias)
All outcomes
Unclear risk Not reported
Incomplete outcome data (attrition bias)
All outcomes
Low risk For all outcomes:
% analysed: 120/120 (100%)
“All patients (n = 120) entered into the study were evaluable for survival rate, date and anatomical location of recurrences, results of autopsy and morbidity of therapy”
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient information to assess whether an important risk of bias exists