UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036255 |
|---|---|
| Receipt number | R000024872 |
| Scientific Title | The Efficacy and Safety of Alectinib in Clinical Practice ; Comparision to Crizotinib, in A Multicenter Retrospective Study. |
| Date of disclosure of the study information | 2019/03/19 |
| Last modified on | 2019/03/27 14:06:37 |
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Basic information
Public title
The Efficacy and Safety of Alectinib in Clinical Practice ; Comparision to Crizotinib, in A Multicenter Retrospective Study.
Acronym
The efficacy of alectinib in a multicenter retrospective study
Scientific Title
The Efficacy and Safety of Alectinib in Clinical Practice ; Comparision to Crizotinib, in A Multicenter Retrospective Study.
Scientific Title:Acronym
The efficacy of alectinib in a multicenter retrospective study
Region
| Japan |
Condition
Condition
ALK rearranged non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy and safety of alectinib in clinical settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to treatment failure
Key secondary outcomes
Progression-free survival
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
All patients who had ALK rearrangement positive results for sensitive immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), or reverse-transcriptase polymerase-chain-reaction (RT-PCR), and all patients with positive results for FISH had more than 15% split signals.
Key exclusion criteria
Nothing
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Matsusaka Municipal Hospital
Division name
Respiratory Centor
Zip code
5150073
Address
1550, Tonomachi, Matsusaka city, Mie, Japan
TEL
0598-23-1515
kentarou_i_0214@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Matsusaka Municipal Hospital
Division name
Respiratory centor
Zip code
5150073
Address
1550, Tonomachi, Matsusaka city, Mie, Japan
TEL
0598-23-1515
Homepage URL
kentarou_i_0214@yahoo.co.jp
Sponsor or person
Institute
Respiratory Centor, Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsusaka Municipal Hospital
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
Matsusaka Municipal Hospital
Address
1550, Tonomachi, Matsusaka city, Mie
Tel
0598-23-1515
mchyanag@city-hosp.matsusaka.mie.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
| 2019 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
Nothing
Publication of results
Published
Result
URL related to results and publications
https://www.jto.org/article/S1556-0864(16)30701-8/fulltext
Number of participants that the trial has enrolled
61
Results
Sixty-one patients were enrolled. Forty-six patients were treated with ALK inhibitors (31 with crizotinib, 28 with alectinib, and 13 with both ALK inhibitors). The response rate was 66.7% for the crizotinib-treated group and 80.8% for the alectinib-treated group. Among all patients, TTF and PFS were significantly prolonged in the alectinib-treated group compared with in the crizotinib-treated group. OS was significantly longer in the alectinib-treated group than in the crizotinib-treated group.
Results date posted
| 2019 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who recieved ALK tyrosine kinase inhibitor (TKI) at six institutions from May 2012 through December 2015 were enrolled in the present study.
Participant flow
Enrollment retrospectively
Adverse events
Nothing (Retrospective study)
Outcome measures
Overall survival
Time to treatment failure
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We reviewed the backgrounds of all patients who were diagnosed with ALK rearranged NSCLC, and assessed the efficacy of ALK inhibitors in clinical practice, using time to treatment failure (TTF), progression-free survival (PFS), and overall survival (OS). We investigated the reasons for discontinuation of ALK inhibitors, patterns of progressive, and adverse events in detail. Electronic medical records were used to obtain patient-specific information. The treating physicians and radiologists in each institution assessed tumor response and toxicities.
Management information
Registered date
| 2019 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024872
