UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056985 |
|---|---|
| Receipt number | R000065123 |
| Scientific Title | The effect of the primary tumor site on survival outcomes and recurrence patterns: a retrospective observational study of patients with stage III non-small cell lung cancer (PRIMARY study) |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/03/04 14:29:05 |
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Basic information
Public title
The effect of the primary tumor site on survival outcomes and recurrence patterns: a retrospective observational study of patients with stage III non-small cell lung cancer (PRIMARY study)
Acronym
Relationship between the primary lesion and prognosis in stage III non-small cell lung cancer
Scientific Title
The effect of the primary tumor site on survival outcomes and recurrence patterns: a retrospective observational study of patients with stage III non-small cell lung cancer (PRIMARY study)
Scientific Title:Acronym
Relationship between the primary lesion and prognosis in stage III non-small cell lung cancer
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 retrospectively the impact of the primary site on survival outcomes and recurrence patterns in patients with stage III non-small cell lung cancer treated by curative chemoradiotherapy.
Basic objectives2
Others
Basic objectives -Others
We will retrospectively investigate the impact of the primary site on survival outcomes such as overall survival, progression-free survival, response rate, and the form of recurrence in patients with stage III non-small cell lung cancer treated by curative chemoradiotherapy after July 2018.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival from the start date of standard chemoradiotherapy
Key secondary outcomes
Progression-free survival starting from the date of commencement of standard chemoradiotherapy, response rate, site of recurrence in cases of recurrence, and radiation irradiation method when performing definitive chemoradiotherapy,
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stage III non-small cell lung cancer patients who began definitive concurrent chemoradiotherapy at a research participating facility from July 2018 to November 2024
Key exclusion criteria
Patients who are judged by the principal investigator (or sub-investigator) at each facility to be unsuitable as subjects, such as those for whom the necessary clinical information for analysis cannot be obtained.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Miyauchi |
Organization
Tohoku University Hospital
Division name
Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 9808574, Japan
TEL
022-717-8539
eisaku.miyauchi.b5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Chikashi |
| Middle name | |
| Last name | Iwasaki |
Organization
Tohoku University Hospital
Division name
Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 9808574, Japan
TEL
022-717-8539
Homepage URL
chikashi.iwasaki.e3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Eisaku Miyauchi
Funding Source
Organization
University grants
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2025 | Year | 02 | Month | 10 | 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
| 2025 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065123
