Bruzzone 1997.
Methods | Randomised controlled trial Trial duration: 4 years June 1990 to October 1992 Trial location: Italy (North West Oncology group) |
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Participants | Number of participants: 111 randomised (57 experimental group, 54 control) Inclusion criteria:
Exclusion criteria:
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Interventions | Intervention: Intraperitoneal INF‐alpha 25,000,000 U on day 1 followed by intraperitoneal carboplatin 400mg/m2 on day 2 every 28 days for 3 courses Control: Intraperitoneal carboplatin 400mg/m2 every 28 days |
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Outcomes |
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Notes | Ethics approval: not reported on Informed consent: participants signed informed consent forms before enrolment into study Funding: source of funding not reported on. Probably under auspices of North West Oncology Group Correspondence with authors: National Institute for Cancer Research and Co‐operative Centers of the North West Oncology Group on 3rd July 2012 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed using random number tables and specific lists of randomisation numbers |
Allocation concealment (selection bias) | Low risk | Treatment allocation was conducted centrally by telephoning the trial office at the Cancer Institute whenever a patient was enrolled |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants was not reported on but measured outcomes unlikely to be affected by lack of blinding as control group received chemotherapy only |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up low and similar in both groups (5/57 intervention, 5/54 control). Intention‐to‐treat analysis was also conducted |
Selective reporting (reporting bias) | Unclear risk | Trial protocol not obtained |
Other bias | Unclear risk | Trial stopped early due to due to toxicities and the higher costs in the interferon arm considering the absence of impressive survival advantage |