NCT00770874

Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer

Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	S-1 + Cisplatin (arm A)	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.
DRUG	Cisplatin (arm B)	Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.

Timeline

• Start date: 2008-09-01
• Primary completion: 2015-12-01
• Completion: 2016-04-01
• First posted: 2008-10-10
• Last updated: 2019-06-21
• Results posted: 2019-06-21

Locations

4 sites across 3 countries: Japan, South Korea, Taiwan