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

NCT ID: NCT02247232

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 793 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2022-02-25

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Z-100

Group Type: EXPERIMENTAL

Z-100

Intervention Type: DRUG

Interventions

Z-100

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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. "

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zeria Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keiichi Fujiwara, Prof,MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Saitama Medical University International Medical Center

Locations

Zeria Invetigative Sites

Tokyo, , Japan

Zeria Investigative Sites

Kuala Lumpur, , Malaysia

Zeria Investigative Sites

Singapore, , Singapore

Zeria Investigative Sites

Seoul, , South Korea

Zeria Investigative Sites

Taipei, , Taiwan

Zeria Investigative Sites

Bangkok, , Thailand

Zeria Investrigative Sites

Hanoi, , Vietnam

Countries

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

Other Identifiers

Z100-01

Identifier Type: -

Identifier Source: org_study_id