UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic adenocarcinoma
Title of the study (Brief title)	A phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic adenocarcinoma
Region	Japan

Condition
Condition	Unresectable locally advanced pancreatic adenocarcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the MTD for unresectable locally advanced pancreatic adenocarcinoma
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Safety
Key secondary outcomes	Response Rate, Overall Survival time, Palliative efficacy

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1.Histologically or cytologically confirmed advanced pancreatic cancer 2.Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery) 3.Performance Status:0-1(ECOG) 4.Patients of age =>20 and 75> 5.WBC>=3,500/mm3,12,000/mm3, neutrophils >=1,500/mm3, platelets=100,000/mm3, hemoglobin >=9.5 g/dl, GOT </=2.0 X ULN, GPT </=2.0 X ULN, AL-P </=2.0 X ULN, total bilirubin <=1.5mg/dl, serum creatinine <=1.2mg/dl, creatinine clearance>=50 ml/min, PaO2 >=70torr or SpO2 >=96% 6.Life expectancy more than 3 months. 7.Written informed consent.
Key exclusion criteria	1.Active infection 2.Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT 3.Severe complication (heart disease, cirrhosis, diabetes) 4.Myocardial infarction within 3 months 5.Active synchronous or metachronous malignancy 6.Pregnant or lactation women, or women with known or suspected pregnancy 7.Symptomatic brain metastasis 8.history of severe drug allergy 9.Peripheral neuropathy 10.Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size	54

Research contact person
Name of lead principal investigator	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Division of Hepatobiliary and Pancreatic Oncology
Address	3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL	06-6972-1181
Email	ioka-ta@mc.pref.osaka.jp

Public contact
Name of contact person	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Division of Hepatobiliary and Pancreatic Oncology
Address	3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL	06-6972-1181
Homepage URL
Email	ioka-ta@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases Division of Hepatobiliary and Pancreatic Oncology
Institute
Department

Funding Source
Organization	Osaka foundation for the prevention of cancer and cardiovascular diseases
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

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	大阪府立成人病センター(大阪府）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 09 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 07 Month 01 Day
Anticipated trial start date	2013 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 08 Day
Last modified on	2018 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013500