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

NCT00770874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2019-06-21

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ken Takizawa, MD · Cancer Institute Hospital

  • Toshiharu Kamura, MD · Yanagawa Hospital

  • Ting-Chang Chang, MD · Chang Gung Memorial Hospital

  • Soon-Beom Kang, MD · Konkuk University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00770874 on ClinicalTrials.gov