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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023217
Receipt No. R000026658
Scientific Title A phase II trial of conversion surgery after induction chemotherapy(Gemcitabine+nab-Paclitaxel) and chemoradiotherapy(RT+S-1) for the patients with locally advanced pancreatic cancer.
Date of disclosure of the study information 2016/09/01
Last modified on 2021/01/19

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Basic information
Public title A phase II trial of conversion surgery after induction chemotherapy(Gemcitabine+nab-Paclitaxel) and chemoradiotherapy(RT+S-1) for the patients with locally advanced pancreatic cancer.
Acronym GENPARTS-CS trial
Scientific Title A phase II trial of conversion surgery after induction chemotherapy(Gemcitabine+nab-Paclitaxel) and chemoradiotherapy(RT+S-1) for the patients with locally advanced pancreatic cancer.
Scientific Title:Acronym GENPARTS-CS trial
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The R0 resection 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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Conversion surgery after Chemotherapy and Radiochemotherapy
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) It is histologically or cytologically diagnosed as pancreatic cancer.
2) Unresectable locally advanced pancreatic cancer according to NCCN guideline 2016
3) Age from 20 to 80 years.
4) ECOG performance status of 0 or 1
5) No previous treatment
6) Labo data to entry satisfy following criteria
1. White blood cell >=3,500/mm3, <12,000/mm3
2. Neutro >=2000/mm3
3. Hb >=9.0/dl
4. T-Bil<=2.0mg/dl (<=3.0mg/dl, after biliary drainage)
5. AST and ALT<=150IU/l
6. serum creatinine<=1.2mg/dl
7. eGFR>=60ml/min
7) Written informed consent
Key exclusion criteria 1) -1 Initially diagnosed as resectable pancreatic cancer
-2 Initially diagnosed as unresectable pancreatic cancer with distant metastasis
2) Age: over 80 years, or less than 20 years
3) ECOG performance status =>2
4) Previous treatments
5) Labodata do not satisfy inclusion criteria
6) No written informed consent
7) Inadequate physical condition, as diagnosed by primary physician
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Minoru
Middle name
Last name Tanabe
Organization Tokyo Medical and Dental University
Division name Hepatobiliary and Pancreatic Surgery
Zip code 113-8519
Address Bunkyo-ku, Yushima 1-5-45, Tokyo, Japan
TEL 03-5803-5928
Email tana.msrg@tmd.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Ban
Organization Tokyo Medical and Dental University
Division name Hepatobiliary and Pancreatic Surgery
Zip code 113-8519
Address Bunkyo-ku, Yushima 1-5-45 TMDU HepatoBiliaryPanc Surg
TEL 03-5803-5928
Homepage URL
Email d-ban.msrg@tmd.ac.jp

Sponsor
Institute Ochanomizu Gastrointestinal Oncology Group
Institute
Department

Funding Source
Organization Self funding
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 Research ethics committee, Tokyo Medical and Dental University
Address Bunkyo-ku, Yushima 1-5-45, Tokyo, Japan
Tel 03-5803-5096
Email syomu1.adm@tmd.ac.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 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 11
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
2016 Year 08 Month 15 Day
Date of IRB
2016 Year 08 Month 19 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 18 Day
Last modified on
2021 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026658

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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