UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038464
Receipt No. R000043835
Scientific Title Phase I/II study of docetaxel and S-1 in previously treated patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2019/11/03
Last modified on 2019/11/01 (Ver. 1)

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Basic information
Public title Phase I/II study of docetaxel and S-1 in previously treated patients with advanced non-small cell lung cancer
Acronym LOGIK0408
Scientific Title Phase I/II study of docetaxel and S-1 in previously treated patients with advanced non-small cell lung cancer
Scientific Title:Acronym LOGIK0408
Region
Japan

Condition
Condition previously treated patients with advanced non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 we conducted this phase I/II trial combining docetaxel and S-1 (tegafur, 5-chloro-2,4-dihydroxypyridine, and potassium oxonate)to determine a recommended dose of docetaxel and a fixed dose of S-1 and to confirm the efficacy and safety of this regimen
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine a recommended dose, ORR
Key secondary outcomes

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 Patients were treated at 3-week intervals with docetaxel on day 1 plus 80 mg/m2 oral S-1 from days 1 to 14
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
75 years-old >=
Gender Male and Female
Key inclusion criteria a cytologically or histologically confirmed diagnosis of incurable previously treated non-small cell lung cancer

no previous use of docetaxel or uracil plus tegafur(UFT)

age between 20-75 years

performance status of <=1 on the Eastern Cooperative Oncology Group scale

an estimated life expectancy of >12 weeks

adequate bone marrow function

a measurable lesion according to the Response Evaluation Criteria in Solid Tumors guidelines version 1.0

provision of written informed consent
Key exclusion criteria active infection, massive ascites or pleural effusion

symptomatic brain metastasis

uncontrollable diabetes mellitus

severe comorbidity such as heart disease or renal disease, interstitial pneumonia, watery diarrhea, active concomitant malignancy

pregnancy or lactation, or other medical problems severe enough to prevent compliance with the protocol

Both of the following conditions were necessary

an interval of at least 4 weeks after the end of final therapy and recovery from the previous treatment
Target sample size 39

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Takayama
Organization Kyoto Prefectural University of Medicine
Division name Department of Pulmonary Medicine
Zip code 6020841
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5513
Email uchino@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Junji
Middle name
Last name Uchino
Organization Kyoto Prefectural University of Medicine
Division name Department of Pulmonary Medicine
Zip code 6020841
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5513
Homepage URL
Email uchino@koto.kpu-m.ac.jp

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
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 prefectural University of Medicine
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
Tel 075-251-5513
Email uchino@koto.kpu-m.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
2019 Year 11 Month 03 Day

Related information
URL releasing protocol N/A
Publication of results Published

Result
URL related to results and publications N/A
Number of participants that the trial has enrolled 39
Results 
The median period of follow-up was 8 months(range, 1~39 months). 

The response to treatment was as follows: complete response, 0; partial response, 3; stable disease, 24; PD, 5; and no effect, 7.
Results date posted
2019 Year 11 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2010 Year 11 Month 05 Day
Baseline Characteristics 
A total of 39 patients (31 men, 8 women; median patient age, 64 years; age range, 46 to 75 years)
Participant flow 
The median number of cycles administered per patient was 3(range, 1~9). The relative dose intensities were 97.7% for docetaxel and 85.7% for S-1, respectively.
Adverse events 
Grade 3 or 4 leukocytopenia, neutropenia, thrombocytopenia, and anemia occurred in 17 (44%), 26 (67%), 0 (0%), and 0 (0%) patients, respectively.
Outcome measures 
The median period of follow-up was 8 months(range, 1~39 months). 

The response to treatment was as follows: complete response, 0; partial response, 3; stable disease, 24; PD, 5; and no effect, 7.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 05 Month 31 Day
Date of IRB
2005 Year 05 Month 31 Day
Anticipated trial start date
2005 Year 05 Month 31 Day
Last follow-up date
2011 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 01 Day
Last modified on
2019 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043835