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Table 2 Completed randomized controlled Phase III trials in cervical cancer

From: Cervical cancer heterogeneity: a constant battle against viruses and drugs

Trial identifier

Brief title

Actual Enrollment

Stage

Arm

Outcomes

NCT00002536

Surgery with or without chemotherapy in treating patients with stage IB cervical cancer

288

IB

Arm I: RHPPL

Arm II: NACT + RHPPL

Not statistically significant

NCT00191100

Comparative study of gemcitabine, cisplatin and radiation versus cisplatin and radiation in cancer of the cervix

515

IIB

to

IVA

Arm I: Gemcitabine + Cisplatin + Brachytherapy

Arm II: Cisplatin + Brachytherapy

PFS (HR = 0.68; 95%

CI = 0.49–0.95, p = 0.0227) and OS

(HR = 0.68; 95% CI = 0.49–0.95,

p = 0.0224) were improved in arm

I vs arm II

NCT00803062

Paclitaxel and cisplatin or topotecan with or without bevacizumab in treating patients with stage IVB, recurrent, or persistent cervical cancer

452

IVB,

recurrent, or

persistent

Arm I: Bevacizumab + Chemotherapy

Arm II: Chemotherapy

Median OS was improved in arm

I vs arm II (17.0 vs. 13.3 months,

HR = 0.71; 98% CI = 0.54–0.95,

p = 0.004)

NCT00003945

Comparison of three chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical cancer

294

IVB,

recurrent, or

persistent

Arm I: Cisplatin + Topotecan

Arm II: Cisplatin

Median OS (9.4 vs. 6.5 months,

P = 0.017) and PFS (4.6 vs. 2.9

months, P = 0.014) were improved

in arm I vs arm II

NCT00064077

Comparison of four combination chemotherapy regimens using cisplatin in treating patients with stage IVB, recurrent, or persistent cancer of the cervix

513

IVB,

recurrent, or

persistent

Arm I: Paclitaxel + Cisplatin

Arm II: Vinorelbine + Cisplatin

Arm III: Gemcitabine + Cisplatin

Arm IV: Topotecan + Cisplatin

Best OS (12.87 months) and PFS

(5.82 months) in arm I

  1. RHPPL Radical hysterectomy and pelvic and para-aortic lymphadenectomy, NACT Neoadjuvant chemotherapy, PFS Progression free survival, HR Hazard ratio, CI Confidence interval, OS Overall survival