UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024114 |
|---|---|
| Receipt number | R000027597 |
| Scientific Title | Phase I study of streptozocin (STZ) plus tegafur-gimeracil-oteracil combination (S-1) for gastroenteropancreatic neuroendocrine tumor |
| Date of disclosure of the study information | 2016/09/23 |
| Last modified on | 2021/09/24 12:17:36 |
* 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
Phase I study of streptozocin (STZ) plus tegafur-gimeracil-oteracil combination (S-1) for gastroenteropancreatic neuroendocrine tumor
Acronym
STS trial
Scientific Title
Phase I study of streptozocin (STZ) plus tegafur-gimeracil-oteracil combination (S-1) for gastroenteropancreatic neuroendocrine tumor
Scientific Title:Acronym
STS trial
Region
| Japan |
Condition
Condition
gastroenteropancreatic neuroendocrine tumor (GEP-NET)(G1,G2,G3)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
See the dose limiting toxicity of Streptozocin (STZ) and S-1 for gastroenteropancreatic neuroendocrine tumor, and decide the recommended dose.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Frequency of Dose Limited Toxicity (DLT)
Key secondary outcomes
Overall Survival(OS)
Progression-free Survival(PFS)
Response Rate(RR)
Adverse event rate
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
streptozocin+S-1
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patient who was diagnosed gastroenteropancreatic neuroendocrine tumor (NET G1,G2,G3 from WHO 2010 classification)
2)1) and surgically non-resectable
3)Patient who underwent at least one or more regimen of systemic chemotherapy except streptozocin, fluorouracil related agents,and transcatheter arterial chemoembolization for liver metastasis.
4)ECOG Performance Status:0 or 1
5)Patient's laboratory results satisfy following criteria within 14 days before entry
hemoglobin level:more than 9.0g/dL
White blood cell:equal to or less than 12000/mm3
Neutrophil:more than 2000/mm3
Platelet:more than 100000/mm3
AST/ALT:equal to or less than 100 IU/L
(equal to or less than 150 IU/L when underwent biliary drainage or choledochojejunostomy)
Total bilirubin:equal to or less than 1.5 mg/dL(equal to or less than 2.0 mg/dL when underwent biliary drainage or choledochojejunostomy)
Creatinine:equal to or less than 1.2 mg/dL
Creatinine clearance:more than 60 mL/min(measured value or Cockcroft-Gault formula)
6)Patient is able to oral intake
Key exclusion criteria
1)Patient who has double or more active cancer
2)Patient who is at risk of becoming pregnant, or in pregnancy. Male patient who is desiring future fertility for partner.
3)Psychiatric patient
4)Patient treated with systemic administration of steroid
5)Patient with pulmonary fibrosis or interstitial pneumonia
6)Patient who has watery diarrhea
7)Patient with an infection (except viral hepatitis)
8)Patient who has a severe complication (cardiac failure, renal failure, hepatic failure, peptic ulcer hemorrhage, paralytic ileus, severe diabetes mellitus)
9)Patient who has a blood transfusion before entry within 14 days
10)Patient who has mild pleural effusion or ascites or cariac effusion on X-ray or ultrasonography
11)Patient who has severe cardiac disease
12)Patient who takes flucytosine, phenytoin or warfarin potassium
13)Patient who has brain metastasis
14)Patient who was judged inadequate to join the trial
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Okusaka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic oncology
Zip code
104-0045
Address
Tsukiji 5-1-1 Chuo-ku Tokyo Japan
TEL
03-3542-2511
tokusaka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yasunari |
| Middle name | |
| Last name | Sakamoto |
Organization
International University of Health and Welfare Atami Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
413-0012
Address
13-1 Higashi-kaigan-cho, Atami-City, Shizuoka, Japan
TEL
0557-81-9171
Homepage URL
yasakamo@iuhw.ac.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3547-5293
CRL_office@ml.res.ncc.go.jp
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
| 2016 | Year | 09 | Month | 23 | 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
14
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
| 2016 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 16 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 16 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 20 | Day |
Last modified on
| 2021 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027597
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
