Table 2.
Main phase I-II clinical trials of various platinum combinations and non-platinum-containing regimens concurrently with external beam irradiation in patients with locally advanced cervical cancer.
| Trial | Year | Phase | Experimental regimen | N | FIGO stage | Primary outcome | Remarks |
|---|---|---|---|---|---|---|---|
| Rao et al. [24] | 2005 | I | Carboplatin Paclitaxel |
15 | IB2-IVA | Feasible | 2-year PFS and OS were 80% and 86%, respectively |
| Colombo et al. [27] | 1997 | II | Carboplatin 5-FU |
28 | IIA-IVA | 5-year OS rate: 66% | ORR, PFS, and OS not different to carboplatin alone |
| Choi et al. [29] | 2008 | II | Cisplatin 5-FU |
57 | IB2-IVA | 5-year OS rate: 70% | ORR: 91.5% |
| Sol et al. [30] | 2009 | II (randomized) |
Cisplatin Paclitaxel |
93 | IB-IVA | 5-year PFS and OS were 79.1% and 80.9%, respectively | Equally efficient but more toxic than cisplatin/5-FU |
| Domingo et al. [32] | 2009 | II | Capecitabine | 60 | IIB-IIIB | ORR: 88% | 1-year PFS and OS were 86% and 95%, respectively |
| Zarbá et al. [34] | 2003 | I-II | Gemcitabine | 36 | IIB-IVA | 3-year OS rate: 72% | 88.8% complete response rate |
| Zhang et al. [35] | 2010 | II | Paclitaxel Nedaplatin | 34 | IIB-IIIB | 2-year OS: 93% | 88% complete response rate |
| Geara et al. [36] | 2010 | II | Paclitaxel | 31 | IB2-IVA | 5-year OS rate: 43% | Inferior to weekly cisplatin |
| Zanetta et al. [37] | 2000 | II | Paclitaxel Ifosfamide Cisplatin |
38 | Bulky locally advanced | ORR: 84.2% | Manageable toxicity |
| Roberts et al. [38] | 2000 | II | Mitomycin C | 160 | IB2-IVA | 4-year PFS: 71% | Better than radiotherapy alone |
| Nguyen et al. [39] | 1991 | II | Mitomycin C 5-FU |
38 | IB-IVA | Median OS: 87 months | Significantly higher OS than 5-FU alone |
| Christie et al. [40] | 1995 | II | Mitomycin C 5-FU |
93 | IB-IVA | 73.2 | 4-year survival: 87% |
| Berclaz et al. [41] | 2002 | II | Cisplatin Mitomycin C 5-FU |
22 | IIB-IVA | ORR: 82% | All patients developed acute haematological toxicity |
| Rose et al. [42] | 2012 | I | Cisplatin Topotecan | 11 | IB-IVA | Feasible | Platinum dose reduced to 30 mg/m2 |
| Fabbro et al. [43] | 2010 | I | Cisplatin Irinotecan |
15 | IB2-IVA | Feasible | 2-year survival: 81% |
FIGO: International Federation of Gynecologic Oncology; CRT: chemoradiotherapy; OS: overall survival; PFS: progression-free survival; ORR: objective response rate; 5-FU: 5-fluorouracil; PVI: protracted venous infusion; N: number of patients.