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

Email

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


Email

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

Email

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


Research Plan
Registered date File name
2023/02/21 R2250_Durva多施設_研究計画書_v1.2_fin.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name