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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014498
Receipt No. R000016075
Scientific Title Phase I/II study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemoradiationtherapy for borderline resectable pancreatic cancer (Prep-03/NS014-1)
Date of disclosure of the study information 2014/07/07
Last modified on 2017/07/10

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Basic information
Public title Phase I/II study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemoradiationtherapy for borderline resectable pancreatic cancer (Prep-03/NS014-1)
Acronym Neoadjuvant GS chemoradationtherapy for borderline resectable pancreatic cancer : Prep-03/NS014-1
Scientific Title Phase I/II study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemoradiationtherapy for borderline resectable pancreatic cancer (Prep-03/NS014-1)
Scientific Title:Acronym Neoadjuvant GS chemoradationtherapy for borderline resectable pancreatic cancer : Prep-03/NS014-1
Region
Japan

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

Objectives
Narrative objectives1 Phase I: To establish the recommended doserecommended dose for neoadjuvant GS radiation therapy.
Phase II: To evaluate the equivalence of safety and resection rate for neoadjuvant GS radiation therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I:Maximum Tolerated Dose, Recommended Dose
Phase II: 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 Other
Interventions/Control_1 Neoadjuvant chemoradiationtherapy withgemcitabine and S-1 followed by surgery.
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

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) borderline resectable Pancreatic cancer
5) all adult who anticipate to undergo pancreatectomy
6) no prior therapy
7) ECOG performance status of 0 or 1
8) adequate organ function
9) oral intake is possible
10) written informed consent
Key exclusion criteria 1) pulmonary fibrosis or interstitial pneumonitis
2) Active double cancer
3) Active infection
4) HBs antigen positive
5) patients are using flucytosine, phenytoin, warfarin
6) pregnant females, possibly pregnant
females
Target sample size 40

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 Division of Surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7205
Email kein_h11@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Nakagawa
Organization Tohoku University Graduate School of Medicine
Division name Division of Integrated Surgery and Oncology
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7205
Homepage URL
Email kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute Study group of preoperative therapy for pancreatic cancer (PREP)
Institute
Department

Funding Source
Organization Study group of preoperative therapy for pancreatic cancer (PREP)
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
2014 Year 07 Month 07 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 Open public recruiting
Date of protocol fixation
2014 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 04 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
2014 Year 07 Month 07 Day
Last modified on
2017 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016075

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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