UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041483 |
|---|---|
| Receipt number | R000044272 |
| Scientific Title | Definitive chemoradiotherapy and consolidation durvalumab for locally advanced non-small cell lung cancer: A multicenter retrospective study |
| Date of disclosure of the study information | 2020/08/20 |
| Last modified on | 2023/02/21 12:28:46 |
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Basic information
Public title
Definitive chemoradiotherapy and consolidation durvalumab for locally advanced non-small cell lung cancer: A multicenter retrospective study
Acronym
Definitive chemoradiotherapy and consolidation durvalumab for locally advanced NSCLC: A multicenter retrospective study
Scientific Title
Definitive chemoradiotherapy and consolidation durvalumab for locally advanced non-small cell lung cancer: A multicenter retrospective study
Scientific Title:Acronym
Definitive chemoradiotherapy and consolidation durvalumab for locally advanced NSCLC: A multicenter retrospective study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main objective is to assess the incidence and risk factors of symptomatic radiation pneumonitis after definitive chemoradiotherapy and consolidation durvalumab for locally advanced non-small cell lung cancer. The secondary objectives are the efficacy and safety of this therapy in the real world setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and risk factors of symptomatic radiation pneumonitis
Key secondary outcomes
Overall survival, Progression-free survival, Failure pattern, Incidence of other severe toxicities, Proportion of patients who receive durvalumab after 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All non-small cell lung cancer patients who initiated curative-intent concurrent chemoradiotherapy (Radiotherapy start date between July 2018 and July 2019).
Key exclusion criteria
Patients who received concurrent durvalumab, had received anti-PD-1 or PD-L1 inhibitors, or had received chest irradiation except whole breast irradiation for breast cancer.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukinori |
| Middle name | |
| Last name | Matsuo |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Radiation Oncology and Image-Applied Therapy
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku,Kyoto
TEL
075-751-3762
ymatsuo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Kishi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Radiation Oncology and Image-Applied Therapy
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku,Kyoto
TEL
075-751-3762
Homepage URL
kishin@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University
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
Kyoto Universtiy Hospital
Address
54 Shogoin Kawahara-cho, Sakyo-ku,Kyoto
Tel
075-751-4748
ethcom@kuhp.kyoto-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
| 2020 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1016/j.cllc.2021.01.017
Number of participants that the trial has enrolled
146
Results
[Primary endpoint: Incidence and risk factor of symptomatic radiation pneumonitis (RP)]
146 patients were analyzed. The median follow-up period was16 months. A majority of the patients had stage III disease (86%), received radiation doses of 60-66 Gy equivalent in 2 Gy fractions (93%) and CBDCA and PTX/Nab-PTX (77%), and underwent ENI (71%) and 3D-CRT(75%). The 12-month incidence of grade 2+ RP was 34.4% [95% CI; 26.7-42.1%]. In the multivariable analysis, lung V20 was a significant risk factor.
Results date posted
| 2021 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 03 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
A multicenter retrospective study
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044272
