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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2022
• Main ID: NCT02247232
• Date of registration: 19/09/2014
• Prospective Registration: Yes
• Primary sponsor: Zeria Pharmaceutical
• Public title: Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
• Scientific title: Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial
• Date of first enrolment: December 2014
• Target sample size: 793
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02247232
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Keiichi Fujiwara, Prof,MD,PhD
• Affiliation: Saitama Medical University International Medical Center

Key inclusion & exclusion 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. "



Age minimum: 21 Years
Age maximum: 79 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Cancer

Intervention(s)

Drug: Z-100

Drug: Placebo

Primary Outcome(s)

Overall survival [Time Frame: 5Years]

Secondary ID(s)

Z100-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors