UMIN-CTR Clinical Trial

Basic information
Public title	The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer.
Acronym	The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer.
Scientific Title	The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer.
Scientific Title:Acronym	The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer.
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy of a biweekly combination neoadjuvant chemotherapy including gemcitabine, nab-paclitaxel, and S-1 (GAS) for patients with Biological borderline resectable pancreatic cancer which have no contact or less than 180 degre of portal vein contact and more tha 500 U/ml of preoperatine Ca19-9 level.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Over all survival after initiation of protocol therapy and median survival time
Key secondary outcomes	-Disease free survival after initiation of protocol therapy -Adverse events -postoperative complication with more than grade 3 -Response rate and normalization rate of tumormarkers after neoadjuvant chemotherapy -Histological responce (Evans grade) -Curative resection rate -Short time outcomes after surgical resection -Reoperation rate, readmission rate and mortality -Initiation and completion rate of adjuvant chemotherapy -Dose intensity

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
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients were assigned to the following levels of GAS regimens. Nab-paclitaxel was administered intravenously at 125 mg/m2, followed by intravenous gemcitabine at 1000 mg/m2. A daily dose of S1 was defined based on the patient's body surface area as follows:<1.25m2,60mg;1.25-1.5m2,80mg;>1.5m2,100mg. S1 administered orally twice a day on days 1-7. The treatment cycle was repeated every 2 weeks. After 6 cycles of the GAS chemotherapy regimen, patients were reevaluated to assess resectability and response to the treatment.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) a histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma (2) no distant metastasis (3) tumor with no contact with the major arteries including the superior mesenteric artery, celiac artery, or common hepatic artery on pretreatment computed tomography (CT) (4)tumor with no contact or less than 180 dgree contact with portal vein (5)More than 500 U/ml of pretreatment serum CA19-9 level (6)Initial treatment (7)0 or 1 of Performance status(ECOG) (8)Age between 20 and 79 (9)dequate hematological, hepatic, and renal functions by hemoglobin >8.0 g/dL, leucocytes >3,000 /mm3 and <12,000 /mm3, neutrophils >1,500 /mm3, platelets >100,000 /mm3, total bilirubin <2.0mg/dL, aspartate aminotransferase and alanine aminotransferase<Normal upper limit x2.5, serum creatinine <1.5mg/dL,
Key exclusion criteria	1.Severe allergy for protcol drugs 2.Histly of active malignant disease within 5 years 3. Active infectious disease 4. >Geade2 of neuropahty 5. Ileus 6. Active interstitional pneumonia 7. Uncontrolable ascites and pleural effusion 8.Uncontrolable diabetes 9.Uncontrolable heart diseases 10.Histry of sevese neurological sidease 11.Pregnancy or possibility of pregnancy 12.Others who were judged to be not appropriate for participation to this clinicalrial by attending physician
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshiaki Murakami
Organization	Hiroshima University Hospital
Division name	Gastrointestinal Surgery
Zip code
Address	1-2-3, Kasumi, Minami-Ku, Hiroshima, JAPAN, 7340037
TEL	082-257-5216
Email	mura777@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naru Kondo
Organization	Hiroshima University Hospital
Division name	Gastrointestinal Surgery
Zip code
Address	1-2-3, Kasumi, Minami-Ku, Hiroshima, JAPAN, 7340037
TEL	082-257-5216
Homepage URL
Email	k-naru-surg@hiroshima-u.ac.jp

Sponsor
Institute	Department of gastrointestinal Surgery, Hiroshima University Hospital
Institute
Department

Funding Source
Organization	Department of gastrointestinal Surgery, Hiroshima University Hospital
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 01 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 01 Month 09 Day
Date of IRB	2018 Year 11 Month 02 Day
Anticipated trial start date	2019 Year 03 Month 04 Day
Last follow-up date	2022 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 01 Month 07 Day
Last modified on	2019 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035070