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

Long 2005.

Methods Randomised Phase III trial
1999 to 2002
Participants 294 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
Outcomes Response rates
Toxicity
OS
Notes 8 patients excluded (1 institutional review board approval error, 2 second active malignancy present, 2 wrong histological type, 1 primary tumour other than cervical cancer, 2 inadequate tissue to confirm metastases). ITT analysis performed
Trial originally had 3 arms but third arm (MVAC) was closed early owing to toxicity and is reported in detail in separate papers
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 performed randomisation
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 8 patients excluded but balanced across groups. ITT analysis performed
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