UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001252 |
|---|---|
| Receipt number | R000001524 |
| Scientific Title | Randomized phase III study of CPT-11 versus Weekly Paclitaxel for unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum. |
| Date of disclosure of the study information | 2008/07/15 |
| Last modified on | 2015/08/31 16:06:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized phase III study of CPT-11 versus Weekly Paclitaxel for unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum.
Acronym
WJOG4007
Scientific Title
Randomized phase III study of CPT-11 versus Weekly Paclitaxel for unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum.
Scientific Title:Acronym
WJOG4007
Region
| Japan |
Condition
Condition
unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare irinotecan with paclitaxel in patients with unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum.
Basic objectives2
Others
Basic objectives -Others
Safety, Efficacy, response rate, progression free survival, rate of subsequent chemotherapy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
overall survival
Key secondary outcomes
response rate, progression free survival, toxicity, rate of subsequent chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CPT-11
Interventions/Control_2
Paclitaxel
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically proven gastric adenocarcinoma
2.unresectable or recurrent gastric cancer refractory to one prior chemotherapy with fluorouracil plus platinum
3.No prior therapy of Taxane or CPT-11
4.No severe peritoneal metastasis
5.Age 20-75 years old
6.PS 0-2
7.>14 days after prior chemotherapy
8.no history of chemotherapy for other malignancy and radiation to abdomen
9.Adequate organ functions
a) WBC>3000/mm3 and <12000/mm3
b) Hb>8.0g/dL
c) Plt>10*104/mm3
d) AST.ALT<100IU/L
e) T-Bil<1.5mg/dL
f) Cre<1.5mg/dL
10.HBV(-)
11.Written informed consent
Key exclusion criteria
1.Serious medical condition such as infection, heart disease
2.Massive pleural effusion or ascites or pericardial effusion
3.Hypersensitivity or neuropathy
4.Interstitial pneumonia
5.CNS metastasis
6.Pregnancy or breast-feeding
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Hironaka |
Organization
Chiba Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
Address
666-2 Nitonacho Chuo-ku Chiba-shi Chiba 260-8717, Japan
TEL
043-264-5431
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
YAKULT HONSHA Co., LTD
DAIICHI SANKYO CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed?term=24190112
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
| 2007 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | 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
| 2008 | Year | 07 | Month | 15 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001524
