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

March 3, 2022 updated by: Zeria Pharmaceutical

Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

793

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Zeria Invetigative Sites
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Zeria Investigative Sites
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Zeria Investigative Sites
  • Singapore
      • Singapore, Singapore
        • Zeria Investigative Sites
  • Taiwan
      • Taipei, Taiwan
        • Zeria Investigative Sites
  • Thailand
      • Bangkok, Thailand
        • Zeria Investigative Sites
  • Vietnam
      • Hanoi, Vietnam
        • Zeria Investrigative Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. FIGO stage (2008): IIIB, cervical cancer;
  2. Pathologically confirmed squamous cell carcinoma of the cervix;
  3. Patients with treatment-naive cervical cancer;
  4. Patients without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node confirmed by CT scanning (Patients need not repeat CT scan at screening if CT data [film or electronic image] within 30 days before informed consent are available and can be provided for central imaging assessment);
  5. Patients ≥21, ≤79 years of age at informed consent;
  6. Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy;
  7. Eastern Cooperative Oncology Group Performance Status: 0-2;

  8. Patients with the following organ functions; (1) WBC ≥3,000/mm3; (2) Platelet count ≥100,000/mm3; (3) Hemoglobin ≥9.5 g/dL (correction by blood transfusion is allowed); (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (6) Renal function:

    1. If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;
    2. If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory;
  9. Patients who are willing to give informed consents. "

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: Z-100
Drug: Z-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5Years
5Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeria Pharmaceutical

Investigators

  • Principal Investigator: Keiichi Fujiwara, Prof,MD,PhD, Saitama Medical University International Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

June 29, 2021

Study Completion (ACTUAL)

February 25, 2022

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (ESTIMATE)

September 23, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z100-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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