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Brief Title: Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
Official Title: Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
Study ID: NCT00770874
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Yanagawa Hospital, Chikushimachi, Yanagawa, Fukuoka, Japan
Cancer Institute Hospital, Ariake, Koto-ku, Tokyo, Japan
Konkuk University Medical Center, Hwayang-dong, Gwangjin-gu, Seoul, Korea, Republic of
Chang Gung Medical Foundation- Linkou, Fu-Hsing Saint Kuei Shan Hsiang, TaoYuan Hsien, Taiwan
Name: Ken Takizawa, MD
Affiliation: Cancer Institute Hospital
Role: STUDY_CHAIR
Name: Toshiharu Kamura, MD
Affiliation: Yanagawa Hospital
Role: STUDY_CHAIR
Name: Ting-Chang Chang, MD
Affiliation: Chang Gung Memorial Hospital
Role: STUDY_CHAIR
Name: Soon-Beom Kang, MD
Affiliation: Konkuk University Medical Center
Role: STUDY_CHAIR