UMIN-CTR Clinical Trial

Basic information
Public title	Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for resectable and borderline resectable pancreatic cancer: Phase II study
Acronym	GEM/nabPTX CRT for advanced pancreatic cancer
Scientific Title	Preoperative gemcitabine plus nab-paclitaxel, concurrent 3D conformal radiation therapy for resectable and borderline resectable pancreatic cancer: Phase II study
Scientific Title:Acronym	GEM/nabPTX CRT for advanced pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	The objective of this trial is to evaluate the treatment efficacy and safety of gemcitabine plus nab-paclitaxel and concurrent radiation therapy for resectable and borderline resectable pancreatic cancer as a preoperative treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Disease free survival, Response (either radiological or pathological), R0 resection rate, safety, pattern of recurrence

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
Interventions/Control_1	Induction chemotherapy with GEM/nPTX followed by GEM/nPTX CRT as a preoperative treatment for 3 months.
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) Patients with resectable and borderline resecable pancreatic cancer (JPS-T3/4) (2) PS(ECOG):0 or 1 (3) Adequate bone marrow reserves, liver/renal function: WBC:>=3,500/mm3, <=12,000/mm3 Neutrophil: >=1,500/mm3 platelet: >=100,000/mm3 Hb: >=9.5g/dL GOT,GPT,ALP: less than 2.5-fold of the upper limit of normal range TBil: <=1.5mg/dL Cr: <=1.2ng/dL Ccr: >=50ml/min (4) Life expectancy more than 6 months. (5) Written informed consent.
Key exclusion criteria	(1)evident infection (2)Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. (3)Severe complication(liver cirrhosis, uncontrolled diabetes etc) (4)the onset of myocardial infarction within 3 months (5)active synchronous malignancy (6) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy (7)history of severe drug allergy (8)neuropathy (9)patients who are judged inappropriate for the entry of the trial by the investigators
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hidenori Middle name Last name Takahashi
Organization	Osaka International Cancer Institute
Division name	Gastroenterological Surgery
Zip code	541-8567
Address	3-1-69, Ohtemae, Chuo-ku, Osaka City, Japan
TEL	0669451181
Email	takahasi-hi@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Hidenori Middle name Last name Takahashi
Organization	Dept. Surgery, Osaka International Cancer Institute
Division name	Gastroenterological Surgery
Zip code	541-8567
Address	3-1-69, Ohtemae, Chuo-ku, Osaka City, Japan
TEL	0669451181
Homepage URL
Email	takahasi-hi@mc.pref.osaka.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Osaka International Cancer Institute
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	Osaka International Cancer Institute
Address	3-1-69, Otemae, Chuo-ku, Osaka City
Tel	06-6945-1181
Email	rinri01@opho.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	大阪国際がんセンター（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 14 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	2017 Year 03 Month 31 Day
Date of IRB	2017 Year 03 Month 31 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2022 Year 05 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	2017 Year 06 Month 14 Day
Last modified on	2019 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031808