UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006161 |
|---|---|
| Receipt number | R000007283 |
| Scientific Title | Phase II study of combination chemotherapy of gemcitabine, TS-1 and regional arterial infusion of nafamostat mesilate for advanced pancreatic cancer. |
| Date of disclosure of the study information | 2011/08/12 |
| Last modified on | 2022/08/20 11:01:32 |
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Basic information
Public title
Phase II study of combination chemotherapy of gemcitabine, TS-1 and regional arterial infusion of nafamostat mesilate for advanced pancreatic cancer.
Acronym
Combination chemotherapy of GEM,TS-1 and NAM for advanced pancreatic cancer.
Scientific Title
Phase II study of combination chemotherapy of gemcitabine, TS-1 and regional arterial infusion of nafamostat mesilate for advanced pancreatic cancer.
Scientific Title:Acronym
Combination chemotherapy of GEM,TS-1 and NAM for advanced pancreatic cancer.
Region
| Japan |
Condition
Condition
Unresectable advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of GEM/TS-1/NAM therapy for advanced pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival, PFS, Disease control rate, one-year survival rate
Key secondary outcomes
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
Gemcitabine was i.v. administered at a fixed dose of 1000 mg/m2 for 30 min on days 1,15 of each 28-day cycle.
nafamostat mesilate is administered via a port-catheter system for 24 h through the common hepatic artery and celiac artery on days 1,15 of each 28-day cycle.
TS-1 60mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks.
TS-1 is administered orally for 2 consecutive weeks every 4 weeks.
Dose of TS-1 per day
BSA
<1.25 m2 80 mg/day
1.25-1.5 m2 100 mg/day
>=1.5 m2 120 mg/day
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Diagnosed as pancreatic cancer Determination of unresectability was evaluated by helical computed tomography scan, abdominal angiography and endoscopic ultrasound by using the criteria defined in the National Comprehensive Cancer Network guidelines for pancreatic cancer. Histologically diagnosis is desirable
2)Patients of age 20-79
3)KPS 7-10
4)Life expectancy more than 3 months
5)hemoglobin >=9.0 g/dl
WBC>=3,000/mm3,12,000/mm3
neutrophils >=1,500/mm3 platelets=100,000/mm3
AST/ALT </=2.5 x ULN
total bilirubin <=2.0 x ULN
serum creatinine <=1.0 x ULN
creatinine clearance>=60 ml/min
PaO2 >= 70 torr
7)No replaced common hepatic artery, gastroduodenal artery and celiac artery
8)Written informed consent
Key exclusion criteria
1)Pulmonary fibrosis or interstitial pneumonitis
2)Active bacterial or fungal infection
3)Uncontrollable heart disease
4)Uncontrollable DM
5)Pregnant or lactating women or women fo childearing potential, and men who want to get partner pregnat
6)Severe drug allergy
7)Simultaneous or metachronous double cancers
8)uncontrollable ascites
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Yanaga |
Organization
Jikei University school of Medicine
Division name
Department of surgery, Division of hepatobiliary pancreatic surgery
Zip code
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Uwagawa |
Organization
Jikei University school of Medicine
Division name
Department of surgery, Division of hepatobiliary pancreatic surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Jikei University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University school of Medicine
Department of surgery
Division of hepatobiliary pancreatic surgery
Organization
Division
Category of Funding Organization
Self funding
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 | 08 | Month | 12 | 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
| 2011 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 12 | Day |
Last modified on
| 2022 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007283
