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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038585
Receipt No. R000043970
Scientific Title A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Date of disclosure of the study information 2019/11/14
Last modified on 2019/11/14

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Basic information
Public title A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Acronym A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Scientific Title A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Scientific Title:Acronym A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Region
Japan

Condition
Condition resectable and borderline resectable (BR-PV) 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 short-term neoadjuvant chemoradiation therapy for resectable and borderline resectable (BR-PV) pancreatic ductal adenocarcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

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 Device,equipment
Interventions/Control_1 To investigate the frequency of histological curative resection following chemoradiation using gemcitabine(1000mg/m2) and S1(60mg/m2) combined with hypofactionated radiotherapy(30Gy/10fr) during two weeks 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 or borderline resectable (BR-PV) pancreatic ductal adenocarcinoma
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 pulmonary fibrosis or interstitial pneumonia
2) Patients with other active cancers
3) Patients who can not take medicine orally
4) Patients with severe allergies
5) Patients with watery diarrhea
6) Patients with severe co-morbid disease
7) Patients seems inadequate for this study by investigator(s)
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Suzuki
Organization Faculty of Medicine, Kagawa University
Division name Department of Gastroenterological Surgery
Zip code 761-0793
Address 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL 087-898-5111
Email szk@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Hironobu
Middle name
Last name Suto
Organization Faculty of Medicine, Kagawa University
Division name Department of Gastroenterological Surgery
Zip code 761-0793
Address 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL 087-898-5111
Homepage URL
Email hsuto@med.kagawa-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Medicine, Kagawa University
Address 1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel 087-898-5111
Email chosa@med.kagawa-u.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 香川大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 14 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
2019 Year 11 Month 14 Day
Date of IRB
2019 Year 11 Month 14 Day
Anticipated trial start date
2019 Year 11 Month 14 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2025 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 11 Month 14 Day
Last modified on
2019 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043970

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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