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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Z-100
Placebo
Sponsored by
Zeria Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. "

Sites / Locations

  • Zeria Invetigative Sites
  • Zeria Investigative Sites
  • Zeria Investigative Sites
  • Zeria Investigative Sites
  • Zeria Investigative Sites
  • Zeria Investigative Sites
  • Zeria Investrigative Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Z-100

Arm Description

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Full Information

First Posted
September 19, 2014
Last Updated
March 3, 2022
Sponsor
Zeria Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02247232
Brief Title
Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
Official Title
Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
February 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeria Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
793 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Z-100
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Z-100
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
5Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: FIGO stage (2008): IIIB, cervical cancer; Pathologically confirmed squamous cell carcinoma of the cervix; Patients with treatment-naive cervical cancer; 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); Patients ≥21, ≤79 years of age at informed consent; Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy; Eastern Cooperative Oncology Group Performance Status: 0-2; 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: If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min; If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory; Patients who are willing to give informed consents. "
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keiichi Fujiwara, Prof,MD,PhD
Organizational Affiliation
Saitama Medical University International Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zeria Invetigative Sites
City
Tokyo
Country
Japan
Facility Name
Zeria Investigative Sites
City
Seoul
Country
Korea, Republic of
Facility Name
Zeria Investigative Sites
City
Kuala Lumpur
Country
Malaysia
Facility Name
Zeria Investigative Sites
City
Singapore
Country
Singapore
Facility Name
Zeria Investigative Sites
City
Taipei
Country
Taiwan
Facility Name
Zeria Investigative Sites
City
Bangkok
Country
Thailand
Facility Name
Zeria Investrigative Sites
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Learn more about this trial

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

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