UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041813 |
|---|---|
| Receipt number | 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 | 2023/09/19 17:27:20 |
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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
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
k-miura@juntendo.ac.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
186
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
Main results already published
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 | 11 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | 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
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047720
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