UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014498 |
|---|---|
| Receipt number | 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 15:45:24 |
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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
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
kein_h11@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Study group of preoperative therapy for pancreatic cancer (PREP)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016075
