Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02247232
Recruitment Status : Active, not recruiting
First Posted : September 23, 2014
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Zeria Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Z-100 Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : December 2014
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: Z-100 Drug: Z-100



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. "

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247232


Locations
Layout table for location information
Japan
Zeria Invetigative Sites
Japan, Japan
Korea, Republic of
Zeria Investigative Sites
South Korea, Korea, Republic of
Malaysia
Zeria Investigative Sites
Malaysia, Malaysia
Singapore
Zeria Investigative Sites
Singapore, Singapore
Taiwan
Zeria Investigative Sites
Taiwan, Taiwan
Thailand
Zeria Investigative Sites
Thailand, Thailand
Vietnam
Zeria Investrigative Sites
Vietnam, Vietnam
Sponsors and Collaborators
Zeria Pharmaceutical
Investigators
Layout table for investigator information
Principal Investigator: Keiichi Fujiwara, Prof,MD,PhD Saitama Medical University International Medical Center

Layout table for additonal information
Responsible Party: Zeria Pharmaceutical
ClinicalTrials.gov Identifier: NCT02247232     History of Changes
Other Study ID Numbers: Z100-01
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: June 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Specific substance maruyama
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents