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

Zeria Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Cervical Cancer

Treatments: Drug: Z-100; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02247232

Z100-01

Details and patient eligibility

About

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.

Enrollment: 793 patients

Sex: Female

Ages: 21 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and 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. "

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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793 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Z-100

Experimental group

Treatment:

Drug: Z-100