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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042892
Receipt No. R000048960
Scientific Title Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Date of disclosure of the study information 2021/01/05
Last modified on 2021/01/05

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Basic information
Public title Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Acronym Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Scientific Title Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Scientific Title:Acronym Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Region
Japan

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

Objectives
Narrative objectives1 Efficacy and safety of nab-paclitaxel monotherapy in patients with non-small cell lung cancer immediately after chemotherapy in combination with immunotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Objective response rate
Key secondary outcomes Progression-free survival, disease control rate, overall survival, and safety.
Subset analysis of efficacy stratified by smoking history and objective response of previous treatment.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Irinotecan monotherapy
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 1) Pathologically or cytologically confirmed extensive stage small cell lung cancer (SCLC).
2) Patients who received immunotherapy in combination with chemotherapy for their first line treatment.
3) Within 8 weeks after end of first line treatment.
4) Patient with evaluable lesion based on RECIST.
5) Age 20 or over.
6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7) No severe organ dysfunction and laboratory data fulfill the standards.
8) Three months and more survival is expected.
9) Written informed consent.
Key exclusion criteria 1) Patients who previously treated with irinotecan
2) Patients with homozygous polymorphisms for UGT1A1*28 and *6 (*28/*28, *6/*6, and *6/*28)
3) Diarrhea (grade 1 or more) before the treatment.
4) Uncontrolable pleural or pericardial effusion.
5) Within 2 weeks after radiotherapy.
6) Operation within 4 weeks.
7) Active double cancer.
8) Active infectious disease.
9) Severe complications including heart failure, hepatic failure, renal failure, paresis of intestine, and ileus.
10) Pregnant woman.
11) HBs antigen positive.
12) Patients who received systemic corticosteroid (10mg or more prednisolone conversion).
13) The subjects whom the doctor excluded.
Target sample size 22

Research contact person
Name of lead principal investigator
1st name Yukihiro
Middle name
Last name Umeda
Organization University of Fukui
Division name Third department of internal medicine
Zip code 910-1193
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL +81776613111
Email umeda@u-fukui.ac.jp

Public contact
Name of contact person
1st name Yukihiro
Middle name
Last name Umeda
Organization University of Fukui
Division name Third department of internal medicine
Zip code 910-1193
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL +81776613111
Homepage URL
Email umeda@u-fukui.ac.jp

Sponsor
Institute Third department of internal medicine, Universtiy of Fukui
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Japanese Red Cross Fukui Hospital, Municipal Tsuruga Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Research Ethics Committee of University of Fukui
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
Tel 0776-61-3111
Email smsien-k@ad.u-fukui.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 福井大学医学部附属病院(福井県)、福井赤十字病院(福井県)、市立敦賀病院(福井県)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 05 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
2021 Year 01 Month 15 Day
Date of IRB
2020 Year 12 Month 21 Day
Anticipated trial start date
2021 Year 01 Month 15 Day
Last follow-up date
2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 04 Day
Last modified on
2021 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048960

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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