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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034410
Receipt No. R000039240
Scientific Title A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer
Date of disclosure of the study information 2018/10/10
Last modified on 2019/04/10

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Basic information
Public title A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer
Acronym A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer
Scientific Title A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer
Scientific Title:Acronym A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate that the efficacy of the induction chemotherapy followed by chemoradiotherapy for borderline resectable pancreatic cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes R0 resection rate
Key secondary outcomes Relapse-free survival
Overall survival
Treatment completion rate
Adverse effect
Pathological response

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
Interventions/Control_1 A total of three courses of nab-Paclitaxel and Gemcitabine followed by TS-1 with concurrent radiotherapy of 45Gy for 5 weeks
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven or radiologically confirmed pancreatic cancer
2) No prior treatment for pancreatic cancer
3) Age between 20 to 85
4) ECOG performance status 0/1
5) White blood cell count above 3000/mm3
Neutrophil count above 1000/mm3
Platelet count above 100000/mm3
Hemoglobin above 8.0 g/dl
Total billirubin below 3.0 mg/dl
AST, ALT below 150 IU/L
Creatinine below 1.5 mg/dl
6) No exclusion criteria
7) Proper informed consent
Key exclusion criteria 1) Contraindication of nab-PTX, GEM, TS-1
2) Pleuritic effusion refractory to diuretics
3) Presence of distant metastasis
4) Presence of concurrent advanced cancer
5) Presence of clinically obvious infection
6) Prior radiotherapy to abdominal lesions
7) Previous history of myocardial infarction within three months
8) Severely mental retardation
9) Current status of pregnancy and lactation, or the possibility of these statuses.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Minoru
Middle name
Last name Kitago
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code 1608582
Address Shinanomachi 35, Shinjuku, Tokyo
TEL 03-3353-1211
Email dragonpegasus@keio.jp

Public contact
Name of contact person
1st name Minoru
Middle name
Last name Kitago
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code 1608582
Address Shinanomachi 35 Shijuku Tokyo
TEL 0333531211
Homepage URL
Email dragonpegasus@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Surgery, Tochigi Medical Center
Department of Surgery, Ichikawa General Hospital, Tokyo Dental College
Department of Surgery, Tokyo Medical Center
Department of Surgery, Saitama National Hospital
Department of Surgery, Hiratsuka City Hospital
Department of Surgery, Fussa Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical committee, Keio University
Address Shinanomachi 35, Shinjuku, Tokyo
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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 独立行政法人 国立病院機構 栃木医療センター 外科 (栃木)
東京歯科大学市川総合病院 外科 (千葉)
独立行政法人国立病院機構東京医療センター 外科 (東京)
独立行政法人 国立病院機構 埼玉病院 外科 (埼玉)
平塚市民病院 外科 (神奈川)
公立福生病院 外科 (東京)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 10 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
2018 Year 10 Month 09 Day
Date of IRB
2019 Year 03 Month 25 Day
Anticipated trial start date
2019 Year 03 Month 25 Day
Last follow-up date
2023 Year 12 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 10 Month 09 Day
Last modified on
2019 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039240

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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