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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028801
Receipt No. R000032961
Scientific Title A Randomized Phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
Date of disclosure of the study information 2017/09/01
Last modified on 2019/08/17

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Basic information
Public title A Randomized Phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
Acronym NEXTAC-TWO study
Scientific Title A Randomized Phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
Scientific Title:Acronym NEXTAC-TWO study
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 extend disability-free survival in elderly patients with advanced non-small cell and pancreatic cancer by early induction of multimodal care with nutritional and exercise intervention
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Disability-free survival
Key secondary outcomes 1. lean body mass
2. physical function
3. nutritional status
4. quality of life
5. safety

Base
Study type Interventional

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

Intervention
No. of arms 2
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 Usual care
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 130

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Takayama
Organization Kyoto Prefectual University of Medicine
Division name Department of Respirology
Zip code 602-8566
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 Tateaki
Middle name
Last name Naito
Organization Shizuoka Cancer Center
Division name Division of thoracic oncology
Zip code 411-8777
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

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

IRB Contact (For public release)
Organization Shizuoka Cancer Center Institutional Review Board
Address 1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel 0559895222
Email t.naito@scchr.jp

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 京都府立医科大学大学(京都府)、静岡県立静岡がんセンター(静岡県)、新潟県立がんセンター(新潟県)、国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 22 Day
Date of IRB
2017 Year 08 Month 22 Day
Anticipated trial start date
2017 Year 11 Month 06 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 23 Day
Last modified on
2019 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032961

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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