Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Intervention
Name: Z-100
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 79 Years
Minimum Age: 21 Years
Gender: Female
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. "
Locations
Zeria Invetigative Sites
Japan, Japan
Status: Recruiting
Contact: Zeria Investigative PIs - +81-3-56447053
Zeria Investigative Sites
South Korea, Korea, Republic of
Status: Recruiting
Contact: Zeria Investigative PIs - +813566447053
Zeria Investigative Sites
Malaysia, Malaysia
Status: Recruiting
Contact: Zeria Investigative PIs - +81356447053
Zeria Investigative Sites
Singapore, Singapore
Status: Recruiting
Contact: Zeria Investigative PIs - +81356447053
Zeria Investigative Sites
Taiwan, Taiwan
Status: Recruiting
Contact: Zeria Investigative PIs - +81356447053
Zeria Investigative Sites
Thailand, Thailand
Status: Not yet recruiting
Contact: Zeria Investigative PIs - +81356447053
Zeria Investrigative Sites
Vietnam, Vietnam
Status: Recruiting
Contact: Zeria Investigative PIs - +81356447053
Start Date
December 2014
Completion Date
December 2021
Sponsors
Zeria Pharmaceutical
Source
Zeria Pharmaceutical
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page