UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042892 |
|---|---|
| Receipt number | 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 | 2024/05/27 13:45:05 |
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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
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
umeda@u-fukui.ac.jp
Sponsor or person
Institute
Third department of internal medicine, Universtiy of Fukui
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
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
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
3
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
Terminated
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
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 29 | Day |
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
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048960
