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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048100
Receipt No. R000054803
Scientific Title Durvalumab after chemoradiotherapy in non-small cell lung cancer harboring driver gene mutation/translocation: a retrospective multicenter study (HOT2101)
Date of disclosure of the study information 2022/06/20
Last modified on 2022/06/19

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Basic information
Public title Durvalumab after chemoradiotherapy in non-small cell lung cancer harboring driver gene mutation/translocation: a retrospective multicenter study (HOT2101)
Acronym HOT2101
Scientific Title Durvalumab after chemoradiotherapy in non-small cell lung cancer harboring driver gene mutation/translocation: a retrospective multicenter study (HOT2101)
Scientific Title:Acronym HOT2101
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluated consecutive patients with locally advanced or postoperative recurrent, unresectable NSCLC harboring driver gene positive who received CRT to describe the clinical characteristics and outcomes of these patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To provide insights into outcomes of durvalumab consolidation efficacy and safety in non-small cell lung cancer harboring driver gene mutation/translocation.
Key secondary outcomes 1. progression free survival
2. overall survival

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically- or cytologically-confirmed NSCLC with driver gene positive defined as EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, and KRAS by December 31, 2021.
2. Patients with locally advanced or postoperative recurrent, unresectable NSCLC.
3. Patients who do not refuse to participate in this study.
Key exclusion criteria Patients who were deemed inappropriate for enrollment by investigators
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hidenori
Middle name
Last name Mizugaki
Organization The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name Department of Advanced Medical Development
Zip code 135-8550
Address 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan
TEL 03-3520-0141
Email hidenori.mizugaki@jfcr.or.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Tsuji
Organization Hokkaido University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code 060-8638
Address North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL 011-706-5911
Homepage URL
Email kosuke_ko17@pop.med.hokudai.ac.jp

Sponsor
Institute Hokkaido Lung Cancer Clinical Study Group(HOT)
Institute
Department

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 Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido
Tel 011-706-7636
Email crjimu@huhp.hokudai.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
2022 Year 06 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 88
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
2021 Year 12 Month 15 Day
Date of IRB
2021 Year 12 Month 22 Day
Anticipated trial start date
2021 Year 12 Month 31 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2024 Year 12 Month 31 Day

Other
Other related information Retrospective observational study

Management information
Registered date
2022 Year 06 Month 19 Day
Last modified on
2022 Year 06 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054803

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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