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. 2013 Jun 6;2013(6):CD009620. doi: 10.1002/14651858.CD009620.pub2

Windbichler 2000.

Methods Randomised controlled trial
Trial duration: 7 years and 3 months, from December 1991 to March 1998
Trial location: 12 Austrian gynaecological and medical centres
Participants Number of participants: 148 randomized (75 intervention group, 73 control group)
Inclusion criteria:
  • Patients who had undergone primary surgical debulking of histologically confirmed invasive epithelial ovarian cancer in FIGO Stages Ic‐III, with WHO performance status 0‐2

  • The percentage of women with FIGO Stage Ic, II, III and IV ovarian cancer in the interferon group were 11%, 14%, 74% and 1% respectively while in the chemotherapy group were 16%, 9%, 69% and 6% respectively

  • Adequate renal function

  • Sufficient hepatic function

  • WBC > 3g/l, platelet count ≥ 100g/l

  • Age less than 75 years


Exclusion criteria:
Patients with concomitant severe cardiovascular disease, life expectancy of less than 3 months, recent second malignancy or history of thromboembolic disease
Interventions Intervention:
Intraperitoneal treatment with interferon‐gamma (IFN‐γ) consisting of 0.1 mg subcutaneously on days 1,3,5, 15, 17 and 19 of each 28‐day cycle PLUS standard chemotherapy given every 4 weeks consisting of 100mg/m2 cisplatin and 600mg/m2 cyclophosphamide
Control:
Standard chemotherapy given every 4 weeks consisting of 100mg/m2 cisplatin and 600mg/m2 cyclophosphamide
Outcomes
  • Overall survival (OS)

  • Progression free survival (PFS), PFS was defined as the interval between the initial surgery and last follow‐up evaluation, diagnosis of progression or death from disease, whichever occurred first

  • Response

  • Toxicity (anaemia, neutropenia, thrombocytopenia, creatinine, bilirubin, SGOT, emesis, alopecia)

Notes Ethics approval: study protocol was approved by the Ethical Committee of the University of Innsbruck Medical School as well as the respective committees of the other participating centres
Informed consent: all participants signed written consent forms before being enrolled
Funding: not mentioned
Correspondence with authors: To C Marth. Department of Obstetrics and Gynaecology, University Hospital, Anichstrasse 35, A‐6020 Innsbruck, Austria 3rd July 2012
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation lists were computer generated
Allocation concealment (selection bias) Low risk Patients were allocated to a treatment arm by the study centre by means of fax transmission
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Not mentioned but unlikely to affect the study outcomes. Control group received chemotherapy only
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not mentioned. Unlikely to affect the study as outcomes are objective. All slides were reviewed by one pathologist
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intention‐to‐treat analysis was done. In the treatment group 6 of 65 patients discontinued due to disease progression. Of the remaining 59 participants, 32 completed 6 cycles of treatment. In the control group, 7 of the 68 participants discontinued due to disease progression. Of the remaining 61 patients, 39 completed 6 cycles of chemotherapy
Selective reporting (reporting bias) Unclear risk Protocol was not available
Other bias Low risk No reason to suspect other bias