UMIN-CTR Clinical Trial

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
Last 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
1st 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