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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027631
Receipt No. R000031630
Scientific Title Randomized phase II study of TJ-3020 in patients with unresectable advanced or recurrent pancreatic cancer receiving nab-Paclitaxel plus Gemcitabine
Date of disclosure of the study information 2017/07/01
Last modified on 2018/01/31

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Basic information
Public title Randomized phase II study of TJ-3020 in patients with unresectable advanced or recurrent pancreatic cancer receiving nab-Paclitaxel plus Gemcitabine
Acronym Randomized phase II study of TJ-3020 in patients with unresectable advanced or recurrent pancreatic cancer receiving nab-Paclitaxel plus Gemcitabine
Scientific Title Randomized phase II study of TJ-3020 in patients with unresectable advanced or recurrent pancreatic cancer receiving nab-Paclitaxel plus Gemcitabine
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuhiro Kodera
Organization Nagoya University, Graduate School of Medicine
Division name Gastroenterorogical Surgery
Zip code
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
1st name
Middle name
Last name Suguru Yamada
Organization Nagoya University, Graduate School of Medicine
Division name Gastroenterorogical Surgery (Hepato-biliary Pancreatic Surgery)
Zip code
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)

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
2017 Year 07 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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