UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000221 |
|---|---|
| Receipt number | 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 15:23:01 |
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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
| Obstetrics 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
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
kaihatu@zeria.co.jp
Sponsor or person
Institute
ZERIA Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000192
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