UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023217 |
|---|---|
| Receipt number | 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 11:01:19 |
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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
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
d-ban.msrg@tmd.ac.jp
Sponsor or person
Institute
Ochanomizu Gastrointestinal Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026658
