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 |
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Participants | Number of participants: 148 randomized (75 intervention group, 73 control group) Inclusion criteria:
Exclusion criteria: Patients with concomitant severe cardiovascular disease, life expectancy of less than 3 months, recent second malignancy or history of thromboembolic disease |
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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 |
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Outcomes |
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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 |
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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 |