UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study of TJ-3020 in patients with unresectable advanced or recurrent pancreatic cancer receiving nab-Paclitaxel plus Gemcitabine
Title of the study (Brief title)	Randomized phase II study of TJ-3020 in patients with unresectable advanced or recurrent pancreatic cancer receiving nab-Paclitaxel plus Gemcitabine
Region	Japan

Condition
Condition	patients with unresectable advanced or recurrent pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the efficacy of TJ-3020 on fatigue in patients with unresectable advanced or recurrent pancreatic cancer who receive nab-paclitaxel plus gemcitabine therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of fatigue and malaise by Cancer Fatigue Scale (CFS)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	gemcitabine and nab-paclitaxel therapy (standard treatment) group Observation period: 8 weeks
Interventions/Control_2	gemcitabine and nab-paclitaxel therapy with oral administration of TJ-3020 group Observation period: 8 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient diagnosed with unresectable advanced or recurrent pancreatic cancer 2) Patient who receive nab-paclitaxel and gemcitabine therapy 3) Estimated overall survival>=3months 4) ECOG-PS 0 or 1 5)Main organs function test almost within normal range: (a)WBC>=3,500/mm3, <=12,000/mm3 (b)Neutrophil>=1,500/mm3 (c)Platelet>=100,000/mm3 (d)Hemoglobin>=9.0g/dl (e)AST, ALT<=100IU/l (f)Total bilirubin<=2.0mg/dl,In biliary drainage cases<3.0mg/dl (g)Creatinine<=1.2mg/dl 6) Age>=20 years old 7) Informed concent was obtained.
Key exclusion criteria	1) Patients who have allergies to traditional Chinese medicine 2) Patients with mental disorder or severe co-morbidity such as heart failure, renal failure, or bowel obstruction 3) Patients with pregnancy 4) Patients with intorerable of oral medications 5) Patients with active cancer of other organs 6) Patients who are judged inappropriate for the study responsible doctor
Target sample size	56

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University, Graduate School of Medicine
Division name	Gastroenterorogical Surgery
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2253
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	Suguru Yamada
Organization	Nagoya University, Graduate School of Medicine
Division name	Gastroenterorogical Surgery (Hepato-biliary Pancreatic Surgery)
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2253
Homepage URL
Email	suguru@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University, Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 04 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031630