UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038464
Receipt number 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 14:45:52

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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 or person

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043835


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name