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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000221
Receipt No. R000000192
Scientific Title Phase III study of Z-100 in uterine cervix cancer patients
Date of disclosure of the study information 2005/09/13
Last modified on 2013/05/22

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Basic information
Public title Phase III study of Z-100 in uterine cervix cancer patients
Acronym Phase III study of Z-100 in uterine cervix cancer patients
Scientific Title Phase III study of Z-100 in uterine cervix cancer patients
Scientific Title:Acronym Phase III study of Z-100 in uterine cervix cancer patients
Region
Japan

Condition
Condition primary uterine cervix cancer
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to examine efficacy of Z-100 in primary uterine cervix cancer patients having radiotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall Survival
Key secondary outcomes Cancer Death-Free Survival
Relapse-Free Survival
Effect of tumor size reduction
Adverse Drug Reaction, Adverse Events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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)
Interventions/Control_2 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)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
79 years-old >=
Gender Female
Key inclusion criteria 1)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
Key exclusion 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
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohiko Umesaki
Organization Wakayama Medical University
Division name Department of gynecology and obstetrics
Zip code
Address 811-1,Kimiidera,Wakayama City,Wakayama, 641-8510,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization ZERIA pharmaceutical Co.,Ltd.
Division name Clinical Research
Zip code
Address 10-11, Nihonbashi, Kobuna-cho, Chuo-ku, Tokyo, 103-8351, Japan
TEL
Homepage URL
Email kaihatu@zeria.co.jp

Sponsor
Institute ZERIA Pharmaceutical Co.,Ltd.
Institute
Department

Funding Source
Organization ZERIA Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JapicCTI-050032
Org. issuing International ID_1 Japan Pharmaceutical Information Center
Study ID_2
Org. issuing International ID_2
IND to MHLW 1986年9月1日 10回

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2004 Year 09 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2013 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000192

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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