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. 2012 Oct 17;2012(10):CD006469. doi: 10.1002/14651858.CD006469.pub2

Long 2006.

Methods Randomised Phase III trial
1999 to 2001
Participants 186 women with histologically confirmed advanced (Stage IVb), recurrent or persistent squamous cell, adenocarcinoma or adenosquamous cervical cancer unsuitable for curative treatment with surgery or radiotherapy, or both
Interventions Arm 1: cisplatin 50 mg/m2 iv d1 q21
Arm 2: cisplatin 50 mg/m2 iv d1 and topotecan 0.75 mg/m2 iv d1‐3 q21
Arm 3: methotrexate 30 mg/m2 iv d1, 15, 22, vinblastine 3 mg/m2 iv d2, 15, 22, doxorubicin 30 mg/m2 iv d2, cisplatin 70 mg/m2 iv d2 q28
Maximum 6 cycles given unless maximum cumulative dose of doxorubicin achieved or progressive disease or unacceptable toxicity
Outcomes Response rates
Toxicity
OS
Notes 6 patients ineligible (1 clerical error, 2 wrong cell type, 1 wrong primary, 1 inadequate pathology tissue, 1 second primary tumour. ITT analysis performed
This paper reports the third arm of trial reported by Long 2006
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients assigned with equal probability using a fixed‐block design
Allocation concealment (selection bias) Low risk GOG Statistical and Data Centre randomly assigned patients
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not documented but OS unlikely to be affected by blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 6 patients excluded balanced across arms. ITT analysis
Selective reporting (reporting bias) Low risk Published report included all pre‐specified outcomes
Other bias Unclear risk MVAC arm closed early owing to toxic deaths