Liao 2010.
Methods | Study design: parallel randomised clinical trial Study duration: November 2005 to November 2007 Duration of follow‐up: date of TACE therapy until the last follow‐up visit (or death) up to November 2009 (median 12 months; range 2–38 months) |
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Participants | Country: China Setting: inpatient, 1 centre People with liver function Child‐Pugh class A or B; ECOG PS 0–2; no distant metastasis; no obvious myelosuppression or renal damage Number: treatment group 24; control group 24 Mean age: treatment group 62 years; control group 63 years Sex (M/F): treatment group 15/9; control group 14/10 Tumour size: treatment group 3.5–11 cm; control group 3.8–11.5 cm Child‐Pugh class (A/B): treatment group 17/7; control group 17/7 Stage (III/IV): treatment group 18/6; control group 16/8 |
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Interventions | Control group: 3–5 courses of TACE with 1‐month interval. TACE comprised hepatic arterial infusion chemotherapy and hepatic artery embolisation. 5‐fluorouracil 1000–1250 mg; cisplatin 70–90 mg; adriamycin 50–60 mg; peripheral embolisation with iodine oil emulsion and central embolisation with gelfoam Treatment group: 3–5 courses of TACE with 1‐month interval; 3‐DCRT delivered 1–2 weeks after the last course of TACE if liver function tests were normal. Radiotherapy: Varian23EX linear accelerator used to deliver 6 MV high‐energy X‐ray radiotherapy. Sum of radiation doses received by each participants ranged from 40 Gy to 66 Gy (median 55 Gy) with 2–2.5 Gy/day, radiation administered in 20–33 sessions |
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Outcomes | According to RECIST, treatment efficacy divided into CR, PR, SD, and PD
Response rate was the sum of CR+PR
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Notes | Source of funding: Project of Quzhou Science and Technology Bureau No information on the compliance and ITT/PP analysis Attempted to contact the first author, without success |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomization was performed by drawing lots." |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported for all outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported for all outcomes |
Incomplete outcome data (attrition bias) All outcomes | High risk | There were postrandomisation dropouts and all relevant outcomes were reported for only 45 participants (i.e. 23 in treatment and 22 in control group). |
Selective reporting (reporting bias) | High risk | 1 predefined outcome (serious adverse events) not reported. Protocol not available |
Other bias | Low risk | No other potential source of bias identified, baseline characteristics comparable |