UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042893 |
|---|---|
| Receipt number | R000048962 |
| Scientific Title | prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB |
| Date of disclosure of the study information | 2021/01/05 |
| Last modified on | 2024/01/07 10:10:21 |
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Basic information
Public title
prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Acronym
prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Scientific Title
prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Scientific Title:Acronym
prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
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
To determine the prognostic value of cisplatin unfit in postoperative lung cancer patients with stage II-III pathology requiring cisplatin-based adjuvant chemotherapy
Basic objectives2
Others
Basic objectives -Others
Reasons why standard postoperative adjuvant chemotherapy could not be administered and alternative treatments
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival by postoperative adjuvant therapy
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who underwent surgery for non-small cell lung cancer between 2010 and 2020, patients with pathological stage II-IIIB requiring postoperative adjuvant chemotherapy as standard treatment will be included.
Key exclusion criteria
Non-complete resection cases
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Toyofumi Fengshi |
| Middle name | |
| Last name | Chen-Yoshikawa |
Organization
Nagoya University
Division name
Graduate School of Medicine, Department of Thoracic Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, JAPAN
TEL
0527442375
tyoshikawa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Nakamura |
Organization
Nagoya University
Division name
Graduate School of Medicine, Department of Thoracic Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, JAPAN
TEL
0527442375
Homepage URL
shota197065@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya university hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel
0527442375
shota197065@med.nagoya-u.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
| 2021 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://nagoya.bvits.com/rinri/publish_document.
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
1400
Results
none
Results date posted
| 2024 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
CDDP unfit patients
Participant flow
retrospective study
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2021 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048962
