Chiu 2005.
Methods | RCT | |
Participants | Country: China Number randomised: 81 Postrandomisation exclusions: 1 (1.2%) Number analysed: 80 Average age: 62 years Females: 14 (17.3%) Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 2 groups Group 1: chemoradiotherapy (N = 36) Further details: external radiotherapy total of 50 to 60 gray given in 25 to 30 fractions over 5 to 6 weeks and two 3‐weekly cycles of cisplatin 60 mg/m² on day 1 and day 22 and 5‐fluorouracil chemotherapy 200 mg/m²/day from day 1 to day 42 Group 2: oesophagectomy (N = 44) Further details: 2‐ or 3‐stage oesophagectomy |
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Outcomes | Outcomes reported were short‐term mortality, long‐term mortality, short‐term adverse events, short‐term serious adverse events, long‐term recurrence, and length of hospital stay | |
Cancer stage/histology | Not reported (must be deemed resectable and have no metastases)/squamous cell carcinoma | |
Tumour location | Mid‐ or lower‐thorax | |
American Society of Anaesthesiologists (ASA) physical status score | Not reported | |
Notes | We attempted to contact the study authors in February 2015 Reason for postrandomisation drop‐out: initially deemed resectable but later considered unresectable Patients were followed up at 6 to 8 week intervals in the 1st year and at 3‐month intervals thereafter Median follow‐up: 1.5 years |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: this information was unavailable. |
Allocation concealment (selection bias) | Unclear risk | Comment: this information was unavailable. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: it was impossible to blind the participants and healthcare providers. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: this information was unavailable. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: there was an imbalance in postrandomisation exclusions. |
Selective reporting (reporting bias) | Low risk | Comment: the trial reported all important outcomes. |
Source of funding | Low risk | Quote: "This study was supported by the Research Grant Council (RGC) of Hong Kong Special Administrative Region, China". |
Other bias | Low risk | Comment: there was no other source of bias. |