Long 2005.
Methods | Randomised Phase III trial 1999 to 2002 |
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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 |
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Outcomes | Response rates Toxicity OS |
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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 |
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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 |