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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041813
Receipt No. R000047720
Scientific Title Prospective observational study of cancer-cachexia and its effect on chemotherapy in patients with previously-untreated advanced non-small cell lung cancer (NEJ050A)
Date of disclosure of the study information 2020/09/16
Last modified on 2020/09/16

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Basic information
Public title Prospective observational study of cancer-cachexia and its effect on chemotherapy in patients with previously-untreated advanced non-small cell lung cancer (NEJ050A)
Acronym Prospective observational study of cancer-cachexia in patients with previously-untreated advanced non-small cell lung cancer (NEJ050A)
Scientific Title Prospective observational study of cancer-cachexia and its effect on chemotherapy in patients with previously-untreated advanced non-small cell lung cancer (NEJ050A)
Scientific Title:Acronym Prospective observational study of cancer-cachexia in patients with previously-untreated advanced non-small cell lung cancer (NEJ050A)
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate decline in quality of life (QOL) about appetite during chemotherapy, adverse events and efficacy of chemotherapy in previously-untreated advanced non-small cell lung cancer with cancer-cachexia.
To elucidate the frequency of cancer-cachexia in previously-untreated advanced non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Transition of FAACT (A/CS) during chemotherapy
Key secondary outcomes Questionnaire for eating-related distress among patients with advanced cancer (QERD), Care Notebook, FACT-G, anchor questionnaire, ECOG PS, KPS, body weight, objective response rate, disease control rate, progression-free survival, overall survival, adverse events, minimally important difference in QERD, validation of QERD, proportion of cachexia

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Pathologically diagnosed NSCLC.
(2) Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC
(clinical stage IVA or IVB) or recurrent NSCLC, not amenable to curative surgery or radiotherapy
(3) Patients who have cachexia (meet one of the following (i) or (ii); (i) weight loss > 5% within the last 6 months, (i) BMI < 20 and weight loss > 2% within the last 6 months).
(4) No prior systemic treatment with systemic anti-cancer therapy for advanced NSCLC. Subjects who received prior adjuvant and/or neo-adjuvant therapies are eligible.
(5) Subjects scheduled to receive chemotherapy.
(6) ECOG PS of 0 to 2.
(7) Aged 20 years or more.
(8) Provided Informed Consent.
Key exclusion criteria (1) Current use of corticosteroids.
(2) Subjects scheduled to receive treatment, but don't fit into cohorts 1, 2, or 3.
(3) Subjects who are unable to accurately complete the QOL questionnaire.
(4) Subjects who are judged by the principal or sub-investigator to be unsuitable for inclusion in this study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Takahashi
Organization Juntendo University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kztakaha@juntendo.ac.jp

Public contact
Name of contact person
1st name Keita
Middle name
Last name Miura
Organization Juntendo University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email k-miura@juntendo.ac.jp

Sponsor
Institute North East Japan Study Group (NEJSG)
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Juntendo University Hospital Independent Ethics Committee
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel 03-5802-1584
Email kenkyu5858@juntendo.ac.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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 16 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
2020 Year 09 Month 11 Day
Date of IRB
2020 Year 09 Month 11 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2020 Year 09 Month 16 Day
Last modified on
2020 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047720

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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