Elit 2012.
Study characteristics | ||
Methods | Trial acronym: none reported, trial run by the Ontario Clinical Oncology Group Design: multicentre, open‐label, 4‐arm phase II randomised trial. The study was terminated early due to poor recruitment. Median duration of follow‐up: not reported, participants were followed until the end of chemotherapy |
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Participants | Women with newly diagnosed epithelial ovarian cancer stage IIB–IV Age, median: 61 (range 34–74) years Gender, n (%) females: 77 (100%) Metastatic disease: not reported Previous VTE, n (%): 4 (5%) |
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Interventions | Intervention 1: standard adjuvant chemotherapy (taxane and platinum‐based) and dalteparin 50 IU/kg SC once daily during the first 3 of 6 cycles of 3‐weekly chemotherapy Intervention 2: standard adjuvant chemotherapy (taxane and platinum‐based) and dalteparin 100 IU/kg SC once daily during the first 3 of 6 cycles of 3‐weekly chemotherapy Intervention 3: standard adjuvant chemotherapy (taxane and platinum‐based) and dalteparin 150 IU/kg SC once daily during the first 3 of 6 cycles of 3‐weekly chemotherapy Study medication was started within 7 days prior to the first 21‐day cycle of chemotherapy and continued until day 21 of cycle 3. Median duration of LMWH was 67 days. |
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Outcomes | Primary outcome: tumour response defined by ≥ 50% reduction in serum CA125 from baseline sustained for ≥ 28 days Secondary outcomes: major bleeding up to 24 hours after the last dose of dalteparin; any bleeding up to 24 hours after the last dose of dalteparin; symptomatic VTE up to 7 days after the last dose of dalteparin; death up to the last day of follow‐up; and compliance with dalteparin administration |
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Notes | Funding, quote: "The Steering Committee wishes to acknowledge the financial support from both the Juravinski Cancer Centre Foundation and Pfizer Canada Inc." Disclosure of potential conflicts of interest, quote: "There are no financial disclosures from any of the authors related to this work except for Dr. Lee who has provided educational lectures and received financial reimbursement from Pfizer Canada Inc." Publication format: full‐text publication |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Concealed randomization was performed centrally … using a computer‐generated, permuted‐block randomization schedule." Comment: adequate method of sequence generation. |
Allocation concealment (selection bias) | Low risk | Quote: "Concealed randomization was performed centrally … using a computer‐generated, permuted‐block randomization schedule." Comment: adequate method of allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "Study outcomes were adjudicated by members of a Central Adjudication Committee masked to treatment assignment." Comment: open‐label study with blinded adjudication of outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "The primary analysis included all patients as randomized." Comment: all participants who were randomised were included in the analysis. |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes indicated in the methods were presented in the results. |