UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000270 |
|---|---|
| Receipt number | R000000330 |
| Scientific Title | feasibility study on CPT-11/TS-1 sequential therapy for TS-1-resistant unresectable gastric cancer |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2013/01/15 22:07:00 |
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Basic information
Public title
feasibility study on CPT-11/TS-1 sequential therapy for TS-1-resistant unresectable gastric cancer
Acronym
feasibility study on CPT-11/TS-1 sequential therapy
Scientific Title
feasibility study on CPT-11/TS-1 sequential therapy for TS-1-resistant unresectable gastric cancer
Scientific Title:Acronym
feasibility study on CPT-11/TS-1 sequential therapy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of CPT-11/TS-1 sequential therapy for TS-1-insensitive gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
anti-tumor effect
Key secondary outcomes
overall survival and progression-free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TS-1 is administered after CPT-11 and the effect is evaluated.
Interventions/Control_2
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
a pathologically-diagnosed gastric cancer
unresectable advanced/reccurrent case
bearing measurable or evaluable lesion
relapsed case after TS-1-based chemotherapy
without CPT-11 as the first-line therapy
WBC 3500-12000,neutrocyte>2000,
platelet>100000, Hb >9.0,T-bil <=1.5
ECOG PS 0-2
oral intake
at least 3-month survival estimated
written informed consent by patient
Key exclusion criteria
infection
diarrhea
colon paralysis or obstruction
interstitial pneumonia or pulmonary fibrosis
massive ascites or pleural effusion
jaundice
hypersensitivity against CPT-11 or S-1
co-administration with 5-flucytosine
pregnant or its possibility
multiple cancers
other severe complications
a patient judged as an inadequate case by his doctor
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soh Saitoh |
Organization
Aomori prefectural central hospital
Division name
Division of medical oncology
Zip code
Address
2-1-1 Higashi-tsukurimichi, Aomori 030-8553
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hirosaki University, School of Medicine
Division name
1st Department of Internal Medicine
Zip code
Address
5 Zaifu-cho, Hirosaki, 036-8562, Aomori
TEL
Homepage URL
Sponsor or person
Institute
1st Department of Internal Medicine,Hirosaki University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Taiho Pharmaceutical Co. Ltd.
Daiichi Pharmaceutical 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
| 2011 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 04 | Month | 01 | Day |
Other
Other related information
Takenori Takahata, Jugoh Itoh, Taroh Satoh, Atsushi Ishiguro, Yoshihumi Matsumoto, Satoshi Tanaka, Soh Saitoh, Hiroshi Tohno, Shinsaku Fukuda, Yasuo Saijo, Yuh Sakata. Sequential irinotecan hydrochloride/S-1 for S-1-resistant gastric cancer: A feasible study, Oncol Lett 3; 89-93, 2011
Management information
Registered date
| 2005 | Year | 10 | Month | 29 | Day |
Last modified on
| 2013 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000330
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
