CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 375 enrolled
Drug / intervention
S-1 + Cisplatin (arm A) +1 moredrug
Likely dose
S-1 + Cisplatin (arm A) 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00770874
NCT00770874Phase 3Completed
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Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix

Taiho Pharmaceutical Co., Ltd.·interventional·Posted Oct 10, 2008·Updated Jun 21, 2019

In Brief

A Phase 3 clinical trial evaluating S-1 + Cisplatin (arm A) and Cisplatin (arm B) for Cervical Cancer. Completed, enrolled 375 participants across 4 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesJapan, South Korea, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2008
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 17.7 years ago

Interventions

S-1 + Cisplatin (arm A)drug

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 (arm B)drug

Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.