Status:
COMPLETED
Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
Lead Sponsor:
Zeria Pharmaceutical
Conditions:
Cervical Cancer
Eligibility:
FEMALE
21-79 years
Phase:
PHASE3
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 radiothe...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- FIGO stage (2008): IIIB, cervical cancer;
- Pathologically confirmed squamous cell carcinoma of the cervix;
- Patients with treatment-naive cervical cancer;
- 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);
- Patients ≥21, ≤79 years of age at informed consent;
- Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy;
- Eastern Cooperative Oncology Group Performance Status: 0-2;
- 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:
- If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;
- If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory;
- Patients who are willing to give informed consents. "
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2022
Estimated Enrollment :
793 Patients enrolled
Trial Details
Trial ID
NCT02247232
Start Date
December 1 2014
End Date
February 25 2022
Last Update
March 4 2022
Active Locations (7)
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1
Zeria Invetigative Sites
Tokyo, Japan
2
Zeria Investigative Sites
Kuala Lumpur, Malaysia
3
Zeria Investigative Sites
Singapore, Singapore
4
Zeria Investigative Sites
Seoul, South Korea