NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000221

Registered date:13/09/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedprimary uterine cervix cancer
Date of first enrollment2004/09/01
Target sample size240
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeOverall Survival
Secondary OutcomeCancer Death-Free Survival Relapse-Free Survival Effect of tumor size reduction Adverse Drug Reaction, Adverse Events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum79years-old
GenderFemale
Include criteria1)FIGO stage II-IVa 2)Histologically proven epidermoid carcinoma 3)No prior treatment for uterine cervix cancer 4)No abdominal paraaortic lymph node metastases 5)Being able to have intravaginal radiation therapy 6)Performance Status(PS) 0,1,2 7)Sufficient organ function (bone marrow, liver, kidney) 8)Written Informed Consent
Exclude criteria1)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

Contact

public contact
Name
Address 10-11, Nihonbashi, Kobuna-cho, Chuo-ku, Tokyo, 103-8351, Japan Japan
Telephone
E-mail kaihatu@zeria.co.jp
Affiliation ZERIA pharmaceutical Co.,Ltd. Clinical Research
scientific contact
Name Naohiko Umesaki
Address 811-1,Kimiidera,Wakayama City,Wakayama, 641-8510,Japan Japan
Telephone
E-mail
Affiliation Wakayama Medical University Department of gynecology and obstetrics