Phase III study of Z-100 in uterine cervix cancer patients

UMIN ID: C000000221

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: primary uterine cervix cancer
• Date of first enrollment: 2004/09/01
• Target sample size: 240
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Z group : During radiotherapy period, Z-100 subcutaneous administration into upper arm (1 ampul, 2 times/week, 3-4 day interval, start within 3 days after radiotherapy). Only response case, after judgement of tumor size reduction, Z-100 subcutaneous administration into upper arm (1 ampul, 1 times/2 week, start within 21 days after judgement of tumor size reduction)
P group : During radiotherapy period, placebo subcutaneous administration into upper arm (1 ampul, 2 times/week, 3-4 day interval, start within 3 days after radiotherapy). Only response case, after judgement of tumor size reduction, placebo subcutaneous administration into upper arm (1 ampul, 1 times/2 week, start within 21 days after judgement of tumor size reduction)

Outcome(s)

• Primary Outcome: Overall Survival
• Secondary Outcome: Cancer Death-Free Survival Relapse-Free Survival Effect of tumor size reduction Adverse Drug Reaction, Adverse Events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Female
• Exclude criteria: 1)Synchronous and metachronous carcinomas within 5 years 2)Serious renal disease except hydronephrosis because of uterine cervix cancer 3)Past history of allergy to cisplatin or other platinum drug (patient planning concomitant use of cisplatin) 4)Past history of serious drug allergy 5)Pregnancy or lactation 6)Patients judged inappropriate for this study by phisicians

Related Information

• Primary Sponsor: ZERIA Pharmaceutical Co.,Ltd.
• Source(s) of Monetary Support: ZERIA Pharmaceutical Co.,Ltd.
• Secondary ID(s): JapicCTI-050032