UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022303 |
|---|---|
| Receipt number | R000025696 |
| Scientific Title | A Phase II trial of neoadjuvant therapy with GEM/IMRT for potentially resectable pancreatic cancer |
| Date of disclosure of the study information | 2016/06/07 |
| Last modified on | 2016/05/13 15:22:51 |
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Basic information
Public title
A Phase II trial of neoadjuvant therapy with GEM/IMRT for potentially resectable pancreatic cancer
Acronym
Neoadjuvant chemoradiation therapy for potentially resectable pancreatic cancer
Scientific Title
A Phase II trial of neoadjuvant therapy with GEM/IMRT for potentially resectable pancreatic cancer
Scientific Title:Acronym
Neoadjuvant chemoradiation therapy for potentially resectable pancreatic cancer
Region
| Japan |
Condition
Condition
potentially resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of neoadjuvant chemoradiation therapy using Gemcitabine combined with IMRT for potentially resectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
disease-free survival, pathological responce rate, incident of adverse event, mortality
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
To investigate the overall survival rate following chemoradiation using Gemcitabine combined with IMRT for potentially resectable pancreatic cancer
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.Patients with Histo-cytologically confirmed pancreatic cancer
2.Patients with radiologically defined patentially borderline resectable pancreatic cancer
3.Patients with Performance status of 0/1
4.Patients who have not undergone chemo and/or radiotherapyPatients with no metastatic disease confirmed by staging laparoscopy
5.Patiants who can oral intake
6.Patients with normal ECG findings
7.Patients with sustained organ function
8.Patients who received informed consent
Key exclusion criteria
1) Patients with lung fibrosis or interstitional pneumonia
2) Patients who can not underwent radiation therapy because of past radiation therapy
3) Severe co-morbid diseases
4) Intractable pleural and pericardical effusion, or ascites
5) Patients with other active cancers
6)Pregnancy or insufficient contraception
7) severe mental illness
8) Patients seems inadequate for this study by investigator(s)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Uemoto |
Organization
Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name
Hepato-pancreato-biliary Surgery and Transplantation
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,
TEL
075-751-3242
tmasui@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Masui |
Organization
Graduate School of Medicine and Faculty of Medicine KyotoUniversity
Division name
Hepato-pancreato-biliary Surgery and Transplantation
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,
TEL
075-751-3242
Homepage URL
tmasui@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Hepato-pamcreato-biliary Surgery and Transplantation,
Graduate School of Medicine and Faculty of Medicine, Kyoto University
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
| 2016 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 13 | 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
| 2016 | Year | 05 | Month | 13 | Day |
Last modified on
| 2016 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025696
