UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060353 |
|---|---|
| Receipt number | R000068994 |
| Scientific Title | A multicentre observational registry study of chemoradiotherapy followed by durvalumab in limited stage small cell lung cancer |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/03/10 10:43:14 |
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Basic information
Public title
A multicentre observational registry study of chemoradiotherapy followed by durvalumab in limited stage small cell lung cancer
Acronym
TSUBAKI study
Scientific Title
A multicentre observational registry study of chemoradiotherapy followed by durvalumab in limited stage small cell lung cancer
Scientific Title:Acronym
TSUBAKI study
Region
| Japan |
Condition
Condition
limited stage small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate real-world PFS (rwPFS) from the start of durvalumab in LS-SCLC patients who are treated with cCRT followed by durvalumab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis population is LS-SCLC patients who are treated with cCRT followed by durvalumab.
Mmedian rwPFS, and rwPFS rates at 18 months and 24 months.
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
1.18 years or older at time of diagnosed as LS-SCLC
2.Pathologically diagnosed as SCLC by tissue or cytology after 27th March 2025
3.Patients who have started to receive CRT (cCRT or sCRT) as 1st line treatment for SCLC
4.Provided written informed consent (for deceased patients, optout will be applicable, if accepted at the site and approved by Ethics Committee)
Key exclusion criteria
1.Patients with any other prior treatment including surgery for SCLC
2.Patients participating in clinical trials as 1st line treatment for SCLC
3.Patients pathologically diagnosed as large cell neuroendocrine carcinoma
4.Patients with multiple cancer at the start time of 1st line treatment
5.Patients diagnosed with SCLC after tissue transformation from NSCLC
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kitagawa |
Organization
AstraZeneca K.K.
Division name
Oncology, Medical,
Zip code
530-0011
Address
Grand Front Osaka Tower B,3-1, Ofuka-cho,Kita-ku, Osaka-city,Osaka,Japan
TEL
06-4802-3600
hiroshi.kitagawa@astrazeneca.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Hayashi |
Organization
AstraZeneca K.K.
Division name
Evidence & Observational Research, Medical
Zip code
530-0011
Address
Grand Front Osaka Tower B, 3-1, Ofuka-cho,Kita-ku, Osaka-city,Osaka,Japan
TEL
06-4802-3600
Homepage URL
yuko.hayashi1@astrazeneca.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
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
Shizuoka Cancer Center Research Ethics Review Committee
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture
Tel
050-989-5222
rinsho_office@scchr.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
静岡県立静岡がんセンター（静岡県）、和歌山県立医科大学附属病院（和歌山県）、東北大学病院（宮城県）、富山県厚生農業協同組合連合会高岡病院（富山県）、横浜市立大学附属病院（神奈川県）、横浜市立市民病院（神奈川県）、地方独立行政法人 神奈川県立病院機構 神奈川県立がんセンター（神奈川県）、愛知県がんセンター（愛知県）、学校法人藤田学園 藤田医科大学病院（愛知県）、京都大学医学部附属病院（京都府）近畿大学医学部、（大阪府）、岡山大学病院（岡山県）、広島大学病院（広島県）、徳島大学病院（徳島県）、長崎大学病院（長崎県）、熊本大学病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Study design:multicentre,observational,secondary data collection study conducted in Japan.
2.Study Population:Patients in this study should meet all of the inclusion criteria and should not meet any of the exclusion criteria.
3.First subject enrolled-Last patient enrolled:Dec2025-Mar2027
4.study data:Patient characteristics,Details of CRT,treatment status,AE,Subsequent treatment,Survival status etc
Management information
Registered date
| 2026 | Year | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068994
