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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003402
Receipt No. R000004124
Scientific Title Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma (NAC GS3)
Date of disclosure of the study information 2010/04/01
Last modified on 2017/10/03

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Basic information
Public title Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma (NAC GS3)
Acronym Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma (NAC GS3)
Scientific Title Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma (NAC GS3)
Scientific Title:Acronym Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma (NAC GS3)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and feasibilty for gemcitabine and S1 therapy as Neoadjuvant against pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes True R0 resection rate; The rate of R0 resection with the normalized post-operative tumor markers
Key secondary outcomes Adverse effect, pathological effect, recurrence free survival, overall survival, patterns of recurrence, reduction rate and normalization rate for tumor marker

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
Interventions/Control_1 Neoadjuvant chemotherapy with gemcitabine and S1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) invasive ductal carcinoma of the pancreas
2) no distant metastasis
3) R0/1 resectable
4) all adult who anticipate to undergo pancreatectomy
5) no prior therapy
6) written informed consent
Key exclusion criteria 1) pulmonary fibrosis or interstitial pneumonitis
2) tumor other than ductal carcinoma
3) distant metastasis
4) R2 resection
5) prior anti-cnacer therapy
6) pregnancy
7) under 18 years old
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Unno
Organization Tohoku University Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Email m_unno@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fuyuhiko Motoi
Organization Miyagi HBPCOG
Division name Coordinating office
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Homepage URL http://www.surg1.med.tohoku.ac.jp/class/hbpcog.html
Email fmotoi@surg1.med.tohoku.ac.jp

Sponsor
Institute Miyagi HBPCOG
Institute
Department

Funding Source
Organization None (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
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
2010 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 Completed
Date of protocol fixation
2010 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2010 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
2010 Year 03 Month 29 Day
Last modified on
2017 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004124

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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