UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035232 |
|---|---|
| Receipt number | R000040142 |
| Scientific Title | A phase II clinical trial of neoadjuvant chemoradiation therapy for pancreatic ductal adenocarcinoma |
| Date of disclosure of the study information | 2018/12/12 |
| Last modified on | 2018/12/12 19:10:38 |
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Basic information
Public title
A phase II clinical trial of neoadjuvant chemoradiation therapy for pancreatic ductal adenocarcinoma
Acronym
A phase II clinical trial of neoadjuvant chemoradiation therapy for pancreatic ductal adenocarcinoma
Scientific Title
A phase II clinical trial of neoadjuvant chemoradiation therapy for pancreatic ductal adenocarcinoma
Scientific Title:Acronym
A phase II clinical trial of neoadjuvant chemoradiation therapy for pancreatic ductal adenocarcinoma
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of neoadjuvant chemoradiation therapy for pancreatic ductal adenocarcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological curative resection (R0 ratio)
Key secondary outcomes
Pathological responce rate, Incident of adverse event, Overall survival, Relapse free survival
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 frequency of histological curative resection following chemoradiation using S1 combined with RT for resectable and borderline resectable (BR-PV) pancreatic ductal adenocarcinoma
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
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with radiologically defined patentially resectable pancreatic cancer
2) Patients who have not undergone radiotherapy to the abdomen
3) Patients who have not undergone chemotherapy within 6 months
4) Patients with Performance status of 0/1
5) Patients with sustained organ function
6) Patients who received informed consent
Key exclusion criteria
1) Patients with other active cancers
2) Patients who can not take medicine orally
3) Patients with severe allergies
4) Patients with watery diarrhea
5) Patients with severe co-morbid disease
6) Patients seems inadequate for this study by investigator(s)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Suzuki |
Organization
Faculty of Medicine, Kagawa University
Division name
Gastroenterological Surgery
Zip code
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
gast@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Suto |
Organization
Faculty of Medicine, Kagawa University
Division name
Gastroenterological Surgery
Zip code
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
Homepage URL
hsuto@med.kagawa-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa 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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 26 | 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
| 2018 | Year | 12 | Month | 12 | Day |
Last modified on
| 2018 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040142
