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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Z-100 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z-100 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5Years |
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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:
Patients who are willing to give informed consents. "
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| Name | Affiliation | Role |
|---|---|---|
| Keiichi Fujiwara, Prof,MD,PhD | Saitama Medical University International Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeria Invetigative Sites | Tokyo | Japan | ||||
| Zeria Investigative Sites |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C031208 | specific substance maruyama |
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|
| Kuala Lumpur |
| Malaysia |
| Zeria Investigative Sites | Singapore | Singapore |
| Zeria Investigative Sites | Seoul | South Korea |
| Zeria Investigative Sites | Taipei | Taiwan |
| Zeria Investigative Sites | Bangkok | Thailand |
| Zeria Investrigative Sites | Hanoi | Vietnam |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |