UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053559 |
|---|---|
| Receipt number | R000061117 |
| Scientific Title | Radical concurrent chemoradiotherapy and Durvalumab therapy for elderly patients |
| Date of disclosure of the study information | 2024/03/18 |
| Last modified on | 2024/02/06 20:08:22 |
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Basic information
Public title
Radical concurrent chemoradiotherapy and Durvalumab therapy for elderly patients
Acronym
Radical concurrent chemoradiotherapy and Durvalumab therapy for elderly patients
Scientific Title
Radical concurrent chemoradiotherapy and Durvalumab therapy for elderly patients
Scientific Title:Acronym
Radical concurrent chemoradiotherapy and Durvalumab therapy for elderly patients
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 the antitumor efficacy and tolerability of cCRT and durvalumab therapy in patients with unresectable locally advanced non-small cell lung cancer in routine practice, and to examine the significance of this therapy for elderly patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Completion rate of radical concurrent chemoradiotherapy, treatment response at the end of radical concurrent chemoradiotherapy, overall survival, progression-free survival in the same regimen (carboplatin + paclitaxel weekly) group
Rate of conversion to durvalumab therapy, reasons for nonconversion, completion rate, percentage of discontinuations, reasons for discontinuation, duration of treatment in discontinued cases, and details of adverse events during the course of treatment
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with confirmed diagnosis of unresectable locally advanced non-small cell lung cancer undergoing cCRT
Patients over 70 years old
Patients for whom medical and prognostic information can be obtained from medical records
Key exclusion criteria
Patients who have requested not to participate in this study based on publicly available information
Other patients deemed ineligible by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Tachihara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunokucho, Chuo-ku, Kobe
TEL
078-382-5668
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiko |
| Middle name | |
| Last name | Yatani |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunokucho, Chuo-ku, Kobe
TEL
078-382-5668
Homepage URL
ayatani@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital Clinical & Translational Research Center
Address
7-5-2 Kusunokucho, Chuo-ku, Kobe
Tel
078-382-5400
ctrcpj-kenkyukanrijimu@med.kobe-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
| 2024 | Year | 03 | Month | 18 | 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 | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 18 | 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
A multi-institutional, retrospective cohort study will be conducted on eligible study subjects initiating radical concurrent chemoradiotherapy within the time period of July 2018 to March 2023.
Management information
Registered date
| 2024 | Year | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061117
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
