Long 2006.
Methods | Randomised Phase III trial 1999 to 2001 |
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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 |
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Outcomes | Response rates Toxicity OS |
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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 |
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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 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 |