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Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer

NCT02247232 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 793

Last updated 2022-03-04

No results posted yet for this study

Summary

This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.

Conditions

Interventions

DRUG

Z-100

DRUG

Placebo

Sponsors & Collaborators

  • Zeria Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Keiichi Fujiwara, Prof,MD,PhD · Saitama Medical University International Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2021-06-29
Completion
2022-02-25

Countries

  • Japan
  • Malaysia
  • Singapore
  • South Korea
  • Taiwan
  • Thailand
  • Vietnam

Study Locations

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Entities

Drugs
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 NCT02247232 on ClinicalTrials.gov