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

NCT02247232 | Completed Phase 3 DMC

• 1 other identifier: Z100-01
• Study Type: interventional
• Target: 793
• Locations: 7 countries
• Sites: 7

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  5Years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Z-100

EXPERIMENTAL

Drug: Z-100

Interventions

Z-100 DRUG

Z-100

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;
• If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory;
• Patients who are willing to give informed consents. "

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (7)

Zeria Invetigative Sites

Tokyo, Japan

Location

Zeria Investigative Sites

Kuala Lumpur, Malaysia

Location

Zeria Investigative Sites

Singapore, Singapore

Location

Zeria Investigative Sites

Seoul, South Korea

Location

Zeria Investigative Sites

Taipei, Taiwan

Location

Zeria Investigative Sites

Bangkok, Thailand

Location

Zeria Investrigative Sites

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

specific substance maruyama

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Keiichi Fujiwara, Prof,MD,PhD

  Saitama Medical University International Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 23, 2014
• Study Start: December 1, 2014
• Primary Completion: June 29, 2021
• Study Completion: February 25, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

KR (1); JP (1); SG (1); TW (1); TH (1); VN (1); MY (1)