UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003269 |
|---|---|
| Receipt number | R000003958 |
| Scientific Title | Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites. |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2013/10/01 23:07:09 |
* 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 II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
Acronym
Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
Scientific Title
Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
Scientific Title:Acronym
Phase II study of gemcitabine and S-1 combination therapy in advanced pancreatic cancer with malignant ascites.
Region
| Japan |
Condition
Condition
pancreatic cancer with ascites
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate efficacy and safety of gemicitabin plus S-1 for advanced pancreatic cancer patients with ascites.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
adverse events, response rate, progression free survival, efficacy against ascites
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
Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S-1(60-100 mg/day, day1-14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
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) Pancreatic cancer histologically confirmed as adenocarcinoma or adenosquamous carcinoma.
2) Patients with mild or moderate ascites.
3) Patients with no previous treatment for pancreatic cancer, except resection.
4) Age: 20 years to less than 80 years.
5) ECOG Performance Status(PS) of 0 or 1.
6) Adequate organ functions.
7) Sufficient oral intake.
8) Written informed consent.
Key exclusion criteria
1) Interstitial pneumonia or fibroid lung.
2) Watery diarrhea.
3) Active infection, excluding viral hepatitis.
4) Serious complications (e.g. heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
5) Ascites only localized at pelvic cavity.
6) Massive ascites.
7) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 1 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration.
8) Sever ECG abnormality.
9) Patients under treatment with flucytosine, phenytoin or warfarin potassium.
10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
11) Sever mental disorder.
12) Inadequate physical condition, as diagnosed by primary physician.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Msafumi Ikeda |
Organization
National Cancer Center Hospital East
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Shimizu |
Organization
National Cancer Center Hospital East
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
sashimiz@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Hepatobiliary and Pancreatic Oncology Division
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding 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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がんセンター東病院（千葉県）
国立がんセンター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 11 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 01 | Day |
Last modified on
| 2013 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003958
