Clinical trial · Interventional
Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial
NCT02247232CI-TRIAL-00056905completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Z-100 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Z-100
- interventionNames
- Drug: Z-100
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5Years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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. "
References
Publications (0)
Data not yet available
No reference posted for this study.