Clinical Trials List
2014-10-01 - 2021-04-20
Phase III
Terminated17
ICD-10C53.9
Malignant neoplasm of cervix uteri, unspecified
Randomized, Double blind, Placebo-controlled Trial of Z-100 plus Radiation Therapy in Patients with Locally Advanced Cervical Cancer — A Phase III trial
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Trial Applicant
CMIC Asia-Pacific
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Sponsor
ZERIA Pharmaceutical Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Cheng-Tao Lin Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 楊育正 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 歐育哲 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Shang-Wen Chen Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 黃家俊 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 鍾邑林 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 蔡介生 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 梁雲 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jo-Ting Tsa Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ming-Yii Huang Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳思遠 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wen-Fang Cheng Division of Obstetrics & Gynecology
- 黃昭源 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 楊育正 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary endpoint for efficacy is the OS, where an event is defined as any death. The final
confirmation date is defined as the date when the survival is confirmed.
The OS is defined as:
Date of death or Date of confirming survival – Date of randomization +1 (day)
Secondary Study Endpoints
The secondary endpoints for efficacy are as follows:
1) Disease-specific survival;
2) Recurrence-free survival;
3) QOL.
Inclution Criteria
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:
a. If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;
b. 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.
Exclusion Criteria
2) Patients who have suffered from cancers other than cervical cancer within 5 years prior to
obtaining consent;
3) Patients with cancer of the cervical stump which is judged by the investigator;
4) Patients who have a history of radiotherapy in the pelvis;
5) In case where a concomitant use of cisplatin is planned, patients who have a history of
hypersensitivity to cisplatin or other medical agents which contain platinum;
6) Patients complicated with a serious drug allergy;
7) Patients with a serious complication (poorly controlled hypertension, hemorrhagic tendency,
connective tissue disease being treated with steroid);
8) Pregnant women, nursing mothers or patients who desire pregnancy during the study period;
9) Patients who have ongoing infection, including known history of human immunodeficiency
virus [HIV], active hepatitis B virus [HBV], or hepatitis C virus [HCV];
10) Other patients considered inappropriate to participate in the study by the investigator
The Estimated Number of Participants
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Taiwan
90 participants
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Global
600 participants
