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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247232
• Other study ID #: Z100-01
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: February 25, 2022

Study information

• Verified date: March 2022
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 793
• Est. completion date: February 25, 2022
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 79 Years

Eligibility

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. "

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Z-100

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Malaysia,  Singapore,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5Years