Clinical trial NCT02247232: Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
Official title: Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-09-23
Enrollment: 793
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.


Eligibility 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. "

Primary outcomes:
measure: Overall survival
timeFrame: 5Years
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Zeria Invetigative Sites
city: Seoul
country: Korea, Republic of
facility: Zeria Investigative Sites
city: Kuala Lumpur
country: Malaysia
facility: Zeria Investigative Sites
city: Singapore
country: Singapore
facility: Zeria Investigative Sites
city: Taipei
country: Taiwan
facility: Zeria Investigative Sites
city: Bangkok
country: Thailand
facility: Zeria Investigative Sites
city: Hanoi
country: Vietnam
facility: Zeria Investrigative Sites
Study officials:
affiliation: Saitama Medical University International Medical Center
name: Keiichi Fujiwara, Prof,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: