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. 2016 Mar 29;2016(3):CD011498. doi: 10.1002/14651858.CD011498.pub2

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
  1. Mid‐ or lower‐thoracic oesophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable.


Exclusion criteria
  1. Participants who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.

  2. Participants > 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.

  3. Participants with compromised cardiac function or creatinine clearance less than 50 mL/min were ineligible.

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
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
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.