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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033574
Receipt No. R000038286
Scientific Title A validation study of biomarkers to predict responders to non-pharmacological multimodal program for advanced cancers
Date of disclosure of the study information 2019/03/31
Last modified on 2018/07/31

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Basic information
Public title A validation study of biomarkers to predict responders to non-pharmacological multimodal program for advanced cancers
Acronym NEXTAC-Three
Scientific Title A validation study of biomarkers to predict responders to non-pharmacological multimodal program for advanced cancers
Scientific Title:Acronym NEXTAC-Three
Region
Japan

Condition
Condition Non-small-cell lung and pancreatic cancer
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To varidate usefulness of biomarkers to predict responders to non-pharmacological multimodal program (NEXTAC program)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Positive predictive value
Key secondary outcomes Sensitivity
Specificity
Negative predictive value

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
Behavior,custom Other
Interventions/Control_1 1. nutritional couseling
2. home-based exercise intervention
3. physical activity intervention
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) >=70 years old and ECOG-PS 0-2
2) newly diagnosed NSCLC/pancreatic cancer in stage III, IV, or post-operative recurrence.
3) They are planned to receive the first-line systemic chemotherapy
4) Having written informed consent
5) More than 3 months of survival was expected
Key exclusion criteria 1) Having disabilities according to the modified KATZ index
2) Having high risks for safe physical assessments and interventions (e.g. Unstable cardiac diseases, Severely symptomatic brain or bone mets, severe phyciatric disease, etc)
3) Having difficulties in swallowing, digesting, and absorbing food
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Takayama
Organization Kyoto Prefectual University of Medicine
Division name Department of Respirology
Zip code
Address Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL 075-251-5513
Email takayama@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tateaki Naito
Organization Shizuoka Cancer Center
Division name Division of thoracic oncology
Zip code
Address 1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL 055-989-5222
Homepage URL
Email t.naito@scchr.jp

Sponsor
Institute Department of Respirology, Kyoto Prefectual University of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2019 Year 03 Month 31 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 31 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
2018 Year 07 Month 31 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038286

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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