UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057834 |
|---|---|
| Receipt number | R000066009 |
| Scientific Title | Multicenter Retrospective Study to Evaluate the Safety and Efficacy of Chemoradiotherapy with Carboplatin for Limited Stage-Small Cell Lung Cancer unfit for CDDP |
| Date of disclosure of the study information | 2025/05/12 |
| Last modified on | 2025/05/12 08:39:43 |
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Basic information
Public title
Multicenter Retrospective Study to Evaluate the Safety and Efficacy of Chemoradiotherapy with Carboplatin for Limited Stage-Small Cell Lung Cancer unfit for CDDP
Acronym
CHAOS trial
Scientific Title
Multicenter Retrospective Study to Evaluate the Safety and Efficacy of Chemoradiotherapy with Carboplatin for Limited Stage-Small Cell Lung Cancer unfit for CDDP
Scientific Title:Acronym
CHAOS trial
Region
| Japan |
Condition
Condition
Limited Stage-Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study retrospectively evaluated the safety and efficacy of treatment in patients with Limited Stage-Small Cell Lung Cancer who were considered unsuitable for CDDP administration and underwent CBDCA-combined chemoradiotherapy .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-year survival rate
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The diagnosis of small cell lung cancer has been pathologically confirmed by cytology or histology.
2)The disease is confirmed to be limited stage (LD), including cases of post-surgical recurrence.
3)The ECOG performance status at the start of treatment is between 0 and 2.
4)Chemoradiotherapy including carboplatin (CBDCA) has been administered.
5)The patient's age at the start of treatment is 18 years or older.
Key exclusion criteria
1)Individuals deemed inappropriate for inclusion in the study by the principal investigator.
2)Individuals who declined to participate in this study through the opt-out process.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Misumi |
Organization
Yokohama Municipal Citizens Hospital
Division name
Department of Respiratory Medicine and Oncology
Zip code
221-0855
Address
1-1 Mitsuzawa-Nishimachi, Kanagawa-ku, Yokohama-shi, Kanagawa, Japan
TEL
045-316-4580
yu02-misumi@hosp.city.yokohama.lg.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Yamanaka |
Organization
Kansai Medical University Hospital
Division name
Department of Thoracic Oncology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata-shi, Osaka, Japan
TEL
09087941603
Homepage URL
https://www.kmu.ac.jp/
yuta1106yamanayt@gmail.com
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Kansai Medical University Hospital
Address
2-5-1 Shinmachi, Hirakata-shi, Osaka, Japan
Tel
072-804-0101
yuta1106yamanayt@gmail.com
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 | 05 | Month | 12 | 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
500
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a multicenter retrospective study.
Management information
Registered date
| 2025 | Year | 05 | Month | 12 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066009
