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. 2012 Jun 13;2012(6):CD007464. doi: 10.1002/14651858.CD007464.pub2

Liu 2010.

Methods RCT, parallel, open, single center, phase III trial
Henan Provincial People’s Hospital, Zhengzhou (China)
Participants n = 39
Sex: 26 male, 13 female
Mean age: 57 ± 18 years
Inclusion criteria:
  • SCLC and BM lesions confirmed by histopathologic and MRI examinations, respectively

  • ECG, blood routine, hepatic and renal function findings normal

Interventions Intervention
Sequential radiotherapy and chemotherapy group: systemic chemotherapies 2 weeks after WBRT (n = 20)
Control
Concomitant radiotherapy and chemotherapy group: parallel systemic chemotherapies and WBRT (n = 19)
WBRT: 1.8 to 2 Gy/time for 18 to 20 times, and the total dose in 4 weeks was 36 Gy
Systemic chemotherapy: teniposide (Vm26) 60 mg/m2, from day 1 to day 3; cisplatin (DDP) 20 mg/m2, from day 1 to day 5. One cycle was defined as a 21‐day therapy duration, with a total of 4 cycles
Outcomes Main and secondary outcomes not differentiated:
  • clinical responses, based on the RECIST standards (4 grades, CR, PR, NC, and PD)

  • median survival time

  • cumulative survival rates

  • acute and subacute toxicity (gastrointestinal, alopecia, renal dysfunction, and other adverse reactions)

  • disease‐related symptoms (including neurologic symptoms)

  • KPS scale assessment

  • body weight, height, physical exam, blood routine, ECG, chest and abdominal CT, brain MRI, bone marrow cells examination and ECT bone scan checks, with lesions measurement results recorded. Blood routine and hepatic and renal function had been re‐examined before and after every treatment cycle

Notes Publication presents preliminary results
Competing interests and information on funding sources not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgment. Mentioned as "randomized" but sequence generation process is not explained in a detailed way. Quote: "patients were randomly divided”. Additional information requested to authors but no answer received
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgment. Additional information requested to authors but no answer received
Blinding of participants and personnel (performance bias) 
 Survival Low risk No information was provided. Probably unblinded. Outcomes measures are not likely to be influenced by lack of blinding
Blinding of participants and personnel (performance bias) 
 Toxicity and disease related symptoms Unclear risk No information was provided. Probably unblinded
Blinding of outcome assessment (detection bias) 
 Survival Low risk No information was provided. Probably unblinded. Outcomes measures are not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) 
 CR, toxicity, quality of life Unclear risk No information was provided
Incomplete outcome data (attrition bias) 
 Survival Low risk No losses in follow‐up were reported
Incomplete outcome data (attrition bias) 
 Toxicity, disease related symptoms, CR Low risk No losses in follow‐up were reported
Selective reporting (reporting bias) Low risk Authors presented results on all outcome measures that were pre‐specified as relevant
We searched for protocol information in the ICTRP
Other bias Low risk The study seems to be free of other sources of bias