UMIN-CTR Clinical Trial

Basic information
Public title	Neoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer; A phase II multicenter trial
Acronym	HOPS-R02
Scientific Title	Neoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer; A phase II multicenter trial
Scientific Title:Acronym	HOPS-R02
Region	Japan

Condition
Condition	Resectable pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To estimate the safety and the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Two year disease free survival
Key secondary outcomes	Overall survival, Progression free survival, R0 resection rate, Response rate of diagnostic imaging, Pathological chemotherapy effect, Adverse events, Rate of preoperative treatment completion, Rate of protocol achievement, Surgical complication

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	1) Preoperative therapy: 2 course of gemcitabine and nab-PTX combination therapy (28days for one course:day1, day8, day15 nab-PTX:125mg/m2/day+GEM:1000mg/m2/day) or total six time administration 2) Surgical resection 3) Postoperative therapy: 4 course of S-1 monotherapy (42days for one course:day1-28 S-1 80mg/m2)
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Resectable pancreatic cancer (JPS7th) 2.Pathological or cytologically proven invasive ductal adenocarcinoma or adenosquamous carcinoma 3.No distant metastasis 4.Age over 20 or under 80 5.ECOG performance status 0-1 6.No history of chemo therapy within 3 years. 7.No history of pancreatic cancer therapy 8.No problems for oral intake 9.Neither peripheral sensory neuropathy nor peripheral motor neuropathy 10.In the case of obstructive jaundice, appropriate bileduct drainage is performed 11.No findings of gastrointestinal infiltration protruding into the lumen and or gastrointestinal bleeding 12.The latest inspection value within 14 days before registration satisfies all of the following. 1) White blood cell count more than 3,000 / mm 3, 2) Hemoglobin more than 9.0 g / dL (no transfuse within 7 days before registration), 3) Platelet count more than 10 x 10 4 / mm 3, 4) Albumin more than 3.0 g / dL, 5) Total bilirubin less than 2.0 mg / dL (3.0 mg / dL or less in case of bileduct drainarge), 6) AST less than 100 U / L (150 IU / L or less in case of bileduct drainarge), 7) ALT less than 100 U / L (150 IU / L or less in case of bileduct drainarge), 8) Serum creatinine less than 1.2 mg / dL, 9) Creatinine clearance 50 ml / min or more 13.Written informed consent
Key exclusion criteria	1.GEM, nab-PTX or fluorinated pyrimidine anticancer drugs have been treated. 2.Severe diarrhea with uncontrolled bowel movement 3.Phenytoin, warfarin potassium, flucytosine are used. 4.History of sever allergic reaction with nab-paclitaxel, paclitaxel or albumin 5.Drug allergy to iodine contrast medium and impossible to perform contrast CT imaging. However, do not exclude the case of contrast-enhanced CT imaging with steroid prophylaxis. 6.Pulmonary fibrosis or interstitial pneumonia 7.Patients with medium or more pleural effusion or ascites 8.Active infection (Clinically stable HBV and chronic viral hepatitis by HCV are excluded). 9.Uncontrolled diabetes 10.Active double cancer (Synchronous double cancer and metachronous double cancer with disease-free period within 3 years). However, lesions such as carcinoma in situ that are cured by topical therapy are not included in active double cancers. 11.Active digestive ulcer 12.Serious complications (heart failure, renal failure, liver failure, intestinal palsy, etc). 13.Myocardial infarction within six months 14.Continuous systemic administration of steroids 15.Sever mental disorder 16.Women who are pregnant / lactating or pregnant or willing, or wish to baby. 17.A man who wishes to become a partner's pregnant. 18.Inappropriate physical condition as diagnosed by the attending physician
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Hirano
Organization	Hokkaido University
Division name	Gastroenterological Surgery II
Zip code	060-8638
Address	N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-7714
Email	satto@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Nakamura
Organization	Hokkaido University
Division name	Gastroenterological Surgery II
Zip code	060-8638
Address	N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-7714
Homepage URL
Email	torunakamura@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido Pancreatic Cancer Study Group (HOPS)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hokkaido University Certified Review Board
Address	N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
Tel	011-706-7934
Email	recjimu@huhp.hokudai.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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 20 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	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 13 Day
Date of IRB	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 20 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 03 Month 20 Day
Last modified on	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036343