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

Bruzzone 1997.

Methods Randomised controlled trial
Trial duration: 4 years June 1990 to October 1992
Trial location: Italy (North West Oncology group)
Participants Number of participants: 111 randomised  (57 experimental group, 54 control)      
Inclusion criteria:
  • Patients with advanced epithelial ovarian cancer

  • Age between 18 and 75 years

  • ECOG performance status  0,1 or 2

  • Participant with FIGO Stage I/II, III, IV ovarian cancer in the intervention group to be 4%, 83% and 13% and the the control group patient in FIGO Stage III and IV were 86% and 14% respectively

  • Good renal, haematological, hepatic and cardiac function

  • More than 3 months life expectancy

  • Patients informed consent


Exclusion criteria:
  • Previous or concomitant malignancy

  • Extra‐abdominal localisations of disease

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
Outcomes
  • Overall survival

  • Progression free survival ‐ assessment of PFS was first progression and death without a confirmed progression

  • Toxicity ‐ leukopenia, anaemia, renal, neurologic and gastroenteric toxicity, flu‐like syndrome

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
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