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

Phase 3

Completed

• Conditions: Cervical Cancer
• Interventions: Drug: Placebo; Drug: Z-100

• Registration Number: NCT02247232
• Lead Sponsor: Zeria Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-23
• Study Start: 2014-12
• Primary Completion: 2021-06-29
• Study Completion: 2022-02-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 793

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. "

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Z-100	Z-100	-

Primary Outcome Measures

Name	Time	Method
Overall survival	5Years

Trial Locations

Locations (3)

Zeria Invetigative Sites; 🇯🇵 Tokyo, Japan

Zeria Investigative Sites; 🇹🇭 Bangkok, Thailand

Zeria Investrigative Sites; 🇻🇳 Hanoi, Vietnam