This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3 study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in patients with stage IVB, recurrent or persistent carcinoma of the cervix.
Japanese phase II study of S-1 in cervical cancer suggested promising response rate and good tolerability. Since recommended chemotherapy for metastatic or recurrent cervical carcinoma is either single-agent Cisplatin or Cisplatin-based combination chemotherapy, this is designed to evaluate the efficacy and safety of S-1 in combination with Cisplatin compared with single-agent Cisplatin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
375
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
Yanagawa Hospital
Chikushimachi, Yanagawa, Fukuoka, Japan
Cancer Institute Hospital
Ariake, Koto-ku, Tokyo, Japan
Konkuk University Medical Center
Hwayang-dong, Gwangjin-gu, Seoul, South Korea
Chang Gung Medical Foundation- Linkou
Fu-Hsing Saint Kuei Shan Hsiang, TaoYuan Hsien, Taiwan
Overall Survival
Time frame: From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three months
Progression Free Survival, Safety
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: About Progression free survival, from the randomization to disease progression or death, whichever came first, assessed up to until primary outcome came each three months, and about safety, from the first treatment to 30 days after the last treatment
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