UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057011 |
|---|---|
| Receipt number | R000065157 |
| Scientific Title | A Multicenter Retrospective Cohort Study to Evaluate Pneumonitis among Limited-stage Small-cell Lung Cancer Patients Who Received Chemoradiotherapy |
| Date of disclosure of the study information | 2025/02/13 |
| Last modified on | 2025/02/13 12:35:18 |
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Basic information
Public title
A Multicenter Retrospective Cohort Study to Evaluate Pneumonitis among Limited-stage Small-cell Lung Cancer Patients Who Received Chemoradiotherapy
Acronym
A Multicenter Retrospective Cohort Study to Evaluate Pneumonitis among Limited-stage Small-cell Lung Cancer Patients Who Received Chemoradiotherapy
Scientific Title
A Multicenter Retrospective Cohort Study to Evaluate Pneumonitis among Limited-stage Small-cell Lung Cancer Patients Who Received Chemoradiotherapy
Scientific Title:Acronym
A Multicenter Retrospective Cohort Study to Evaluate Pneumonitis among Limited-stage Small-cell Lung Cancer Patients Who Received Chemoradiotherapy
Region
| Japan |
Condition
Condition
Limited-stage Small-cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the incidence of pneumonitis, factors involved in the development of symptomatic pneumonitis, and timing of onset of pneumonitis in concurrent chemoradiotherapy using accelerated hyperfractionated irradiation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of symptomatic pneumonitis (= Grade 2 or higher) as the primary event and the risk factors involved in its development in patients who received accelerated hyperfractionated irradiation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive cases that meet all of the following:
1) Patients diagnosed with limited-stage small-cell lung cancer
2) Patients who started chemoradiotherapy with curative intent at a standard radiation dose (45 Gy or more for accelerated hyperfractionation, 60 Gy or more for conventional irradiation) between 2015 and 2021 (including once-daily irradiation and sequential chemoradiotherapy
Note: If radiotherapy is initiated for curative intent, patients are considered eligible even if radiotherapy is suspended or terminated during the course of treatment due to adverse events or other reasons. Therefore, in cases where a lower dose than the standard dose was administered, the reason should be confirmed, and eligibility should be determined.
3) Patients that received cisplatin/etoposide or carboplatin/etoposide as combination chemotherapy
Key exclusion criteria
Cases meeting any of the following criteria will be excluded from the study:
1) Patients receiving chemoradiotherapy as adjuvant treatment after surgery
2) Patients who choose to opt-out
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba University Hospital
Division name
Department of Respiratory Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
suzutaku@chiba-u.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Saito |
Organization
Chiba University Hospital
Division name
Department of Respiratory Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
gosaito@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
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
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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 | 13 | 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
| 2024 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | 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
Information retrospectively collected from eligible patients at participating facilities will be registered in the REDcap system of the Data Management Division, Center for Clinical Research and Innovation, Osaka Metropolitan University, and analyzed
Management information
Registered date
| 2025 | Year | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065157
