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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032642
Receipt No. R000037222
Scientific Title Phase 2 study of S-1 and concurrent breath controlled intensity modulated radiation therapy for locally advanced unresectable pancreatic cancer.
Date of disclosure of the study information 2018/05/21
Last modified on 2019/05/20

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Basic information
Public title Phase 2 study of S-1 and concurrent breath controlled intensity modulated radiation therapy for locally advanced unresectable pancreatic cancer.
Acronym Phase 2 study of S-1 and concurrent IMRT for locally advanced unresectable pancreatic cancer.
Scientific Title Phase 2 study of S-1 and concurrent breath controlled intensity modulated radiation therapy for locally advanced unresectable pancreatic cancer.
Scientific Title:Acronym Phase 2 study of S-1 and concurrent IMRT for locally advanced unresectable pancreatic cancer.
Region
Japan

Condition
Condition Pancreatic duct adenocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate efficacy and safety of S-1 and concurrent IMRT for locally advanced unresectable pancreatic cancer patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Completion rate, CA19-9 response rate, Progression free survival, distant metastasis free survival, Overall survival, Rate of adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients receive concurrent IMRT with S-1.
S-1; 80mg/m2 on the irradiated day
Radiotherapy; a total dose of 70 Gy in 28 fractions at gross tumor volume (GTV) and 50.4 Gy in 28 fractions at border of planning target volume (PTV)
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven adenocarcinoma and consistent with adenocarcinoma by diagnostic imaging.
2) Diagnosed with locally advanced unresectable by contrast enhancement CT or MRI and suitable for concurrent chemoradiotherapy.
3) Diagnosed with inoperable cancer by gastroenterologist or surgeon.
4) Without obvious organ metastases by EOB-MRI or contrast enhancement CT.
5) ECOG PS of 0, 1 or 2.
6) Preserved oral intake function.
7) Adequate organ function.
8) Written informed consent.
Key exclusion criteria 1) Previous history of radiotherapy for pancreatic cancer.
2) Moderate pleural effusion or ascites or cytologically proven pleural or abdominal dissemination.
3) Gastric or duodenal ulcer due to tumor invasion.
4) Active gastric or duodenal ulcer
5) Watery diarrhea
6) Patients requiring the administration of phenytoin, warfarin potassium or flucytosine.
7) Interstitial pneumonia or lung fibrosis.
8) Active infection.
9) Severe complication, such as heart disease, renal disease, and hepatic disease.
10) Patients requiring systemic steroids medication.
11) Psychosis.
12) Drug allergy.
13) Pregnant or lactating women of women of child bearing potential and men who want to get partner pregnant.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Someya
Organization Sapporo Medical University, School of Mecidine
Division name Department of Radiology
Zip code 060-8543
Address S1W16, chuo-ku, Sapporo
TEL +81-11-611-2111
Email someya@sapmed.ac.jp

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Someya
Organization Sapporo Medical University, School of Mecidine
Division name Department of Radiology
Zip code 060-8543
Address S1W16, chuo-ku, Sapporo
TEL +81-11-611-2111
Homepage URL http://web.sapmed.ac.jp/hohsyasen/index.html
Email someya@sapmed.ac.jp

Sponsor
Institute Department of Radiology, Sapporo Medical University, School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional review board
Address S1W16, chuo-ku, Sapporo
Tel +81-11-611-2111
Email ji-rskk@sapmed.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 札幌医科大学付属病院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 21 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
2018 Year 03 Month 30 Day
Date of IRB
2018 Year 03 Month 03 Day
Anticipated trial start date
2018 Year 05 Month 21 Day
Last follow-up date
2024 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
2018 Year 05 Month 19 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037222

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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