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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021484
Receipt No. R000024781
Scientific Title Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy in locally advanced pancreatic ductal adenocarcinoma
Date of disclosure of the study information 2016/04/01
Last modified on 2018/09/17

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Basic information
Public title Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy in locally advanced pancreatic ductal adenocarcinoma
Acronym PDAC-GS/GA-rP2
Scientific Title Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy in locally advanced pancreatic ductal adenocarcinoma
Scientific Title:Acronym PDAC-GS/GA-rP2
Region
Japan

Condition
Condition Pancreatic ductal adenocarcinoma
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness and safety of the GEM /S-1 and the GEM/nab-PTX combination therapy in a randomization second aspect examination as preoperative therapy promising clinical benefit
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival time
Key secondary outcomes Rate of curative resection, Completion rate of protocol therapy, Reccurence type, overall survival time, and safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm 1:Gem+S-1 q3wx2times
Patients receive S-1(80mg/m2/day,day1-14) plus Gemcitabine(1000mg/m2,day1,15) every 3 weeks,2 times.
Interventions/Control_2 Arm 2:Gem+nab-PTX q4wx2times
Patients receive nab-PTX(125mg/m2, day1,15,22) plus Gemcitabine(1000mg/m2, day1,15,22) every 4 weeks, 2 times.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
2. Patients of age =>20
3. Performance Status:0-1(ECOG)
4. Resectable pancreatic cancer
5. Life expectancy more than 6 months.
6. Sufficient organ functions.
(1) neutrophils >=1,500/mm3
(2) platelets >=100,000/mm3
(3) hemoglobin >=9.0g/dl
(4) AST(GOT)/ALT(GPT) <=150IU
(5) total bilirubin <=2.0mg/dl
(or <=3.0mg/dl if biliary drainage were present)
(6) serum creatinine <=1.2mg/dl
(7) creatinine clearance>=60ml/min
7. No treatment before application for this tumor
8. Written informed consent.
Key exclusion criteria 1) Unresectable pancreatic cancer
2) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
3) Watery diarrhea
4) Severe infection
5) Severe complication
(heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
6) Massive pleural or abdominal effusion.
7) Metastasis to central nervous system.
8) Active synchronous or metachronous malignancy other than carcinoma in situ.
9) Regular use of frucitocin, fenitoin or warfarin
10) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
11) Severe mental illness
12) Severe allergy for drugs
13) Patients who are judged inappropriate for the entry into the study by the investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Eguchi
Organization Graduate school of medicine, Osaka university
Division name Department of Gastroenterological surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Email heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Akita
Organization Graduate school of medicine, Osaka university
Division name Department of Gastroenterological surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Homepage URL
Email hakita@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Clinical study group of Osaka university, Hepato-Biliary- Pancreatic group
Institute
Department

Funding Source
Organization Clinical study group of Osaka university, Hepato-Biliary- Pancreatic group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 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
Date of protocol fixation
2016 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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
2016 Year 03 Month 15 Day
Last modified on
2018 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024781

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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