GOG-204 — Phase III Trial of Four Cisplatin-Containing Doublet Combinations in Stage IVB, Recurrent, or Persistent Cervical Carcinoma

Phase 3 · 2009 · Cervical Cancer

Design

Randomized phase III trial comparing four cisplatin-based doublets (cisplatin/paclitaxel [reference] vs cisplatin/vinorelbine vs cisplatin/gemcitabine vs cisplatin/topotecan) in advanced/recurrent cervical carcinoma.

Population

Women with stage IVB, recurrent, or persistent cervical carcinoma not amenable to curative surgery or radiotherapy.

Primary Endpoint

Overall survival

Key Result

No doublet was superior to cisplatin/paclitaxel; hazard ratios for death versus PC were 1.15 (VC), 1.32 (GC), and 1.26 (TC), and trends in response rate, PFS, and OS favored cisplatin/paclitaxel (median OS ~12.9 months).

Guideline Impact

Established cisplatin/paclitaxel as the standard chemotherapy backbone in cervical cancer guidelines (NCCN)