UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027631 |
|---|---|
| Receipt number | 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 22:34:14 |
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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
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
suguru@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031630
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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