UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014923 |
|---|---|
| Receipt number | R000017365 |
| Scientific Title | The prospective, observational study that paid attention to adjuvant chemotherapy in elderly patients with resection of non-small-cell lung cancer |
| Date of disclosure of the study information | 2014/08/22 |
| Last modified on | 2021/08/27 14:15:50 |
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Basic information
Public title
The prospective, observational study that paid attention to adjuvant chemotherapy in elderly patients with resection of non-small-cell lung cancer
Acronym
LOGIK1304
Scientific Title
The prospective, observational study that paid attention to adjuvant chemotherapy in elderly patients with resection of non-small-cell lung cancer
Scientific Title:Acronym
LOGIK1304
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We prospectively accumulate the non-small-cell lung cancer resection case of the elderly patients (>=75 years) in multi-center, grasp the present conditions of adjuvant chemotherapy (ACT), observe progress after the operations which paid attention to presence or absence of ACT and collect fundamental information about the effectiveness and safety of ACT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Baseline change of Karnofsky Performance status score
Key secondary outcomes
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with histologically confirmed NSCLC
2) Patients with above pathological stage IB and complete resection (including R0 (un))
3) Patients with no prior treatment of chemotherapy or radiation therapy on NSCLC
4) Patients that are able to treat adjuvant chemotherapy within 8 weeks
5) Patients with more than 60% of Karnofsky Performance Status at the registration
6) Age >=75 years (at the registration)
7) Written informed consent
8) patients with adequate organ function (within 2 weeks before registration):
1.Neutrophils >=3500 /mm3 <12000/mm3
2.Platelet >= 100000/mm3
3.Hemoglobin >= 9.0g/dL
4.AST and ALT < 2 x ULN
5.Total bilirubin < 1.5 mg/dl
6.Serum creatinine <= 1.2 mg/dl
7. PaO2>= 60 Torr or SpO2 >= 92%
Key exclusion criteria
1) Patients with incomplete resection of NSCLC
2) Patients with past history of severe drug allergy
3) Patients with clinically problematic active severe complications
4) Patients with active concomitant malignancy in another organs
5) Any other patients who are regarded as unsuitable for this study by the investigators
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tokujiro |
| Middle name | |
| Last name | Yano |
Organization
National Hospital Organization Beppu Medical Center
Division name
Department of Respiratory Surgery
Zip code
874-0011
Address
1473 Ooaza-Uchikamado, Beppu-city, 874-0011 Japan
TEL
0977-67-1111
sfukuyam@beppu2.hosp.go.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Fukuyama |
Organization
National Hospital Organization Beppu Medical Center
Division name
Department of Respiratory Surgery
Zip code
874-0011
Address
1473 Ooaza-Uchikamado, Beppu-city, 874-0011 Japan
TEL
0977-67-1111
Homepage URL
sfukuyam@beppu2.hosp.go.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Network Fukuoka Ethics committee
Address
3-1-1 Maidashi Higashi-ku Fukuoka, Japan, Fukuoka
Tel
092-643-7171
mail@crnfukuoka.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
| 2014 | Year | 08 | Month | 22 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
We prospectively accumulate the non-small-cell lung cancer resection case of the elderly patients (>=75 years) in multi-center, grasp the present conditions of adjuvant chemotherapy (ACT), observe progress after the operations which paid attention to presence or absence of ACT and collect fundamental information about the effectiveness and safety of ACT.
Management information
Registered date
| 2014 | Year | 08 | Month | 22 | Day |
Last modified on
| 2021 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017365
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
