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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035812
Receipt No. R000040750
Official scientific title of the study Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer
Date of disclosure of the study information 2019/02/08
Last modified on 2019/02/08

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Basic information
Official scientific title of the study Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer
Title of the study (Brief title) Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This trial evaluated the efficacy and toxicity of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer (NSCLC).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate
Key secondary outcomes Progression-free survival
Overall survival
safety

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 S1 is administered orally twice daily for 14 days a day, according to the body surface area, followed by 7 days off. PTX 80 mg / m 2 is administered on Day 1, 8 by drip infusion. One cycle is 21 days.
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) A case in which definitive diagnosis of non-small cell lung cancer was obtained by histology or cytology
2) Cases with measurable lesions
3) Patients with a history of chemotherapy treatment containing 1 platinum regimen over 1 regimen (treatment history of surgical therapy and radiotherapy is not limited)
4) Cases with 4 weeks or more have passed since the end of previous chemotherapy
5) Case of over 20 years old
6) Case of Performance Status 0-1 of ECOG
7) Cases with sufficient bone marrow function and organ function
8) Cases in which survival for more than 2 months can be expected
9) Cases with oral administration
10) Case informed consent obtained document from patient himself
Key exclusion criteria 1: Cases with serious complications
Interstitial pneumonia
Serious heart disease
diabetes which is difficult to control
Serious infectious diseases
2: Cases with other active organs and overlapping cancers
3: Patients with a history of severe hypersensitivity
4: Case in which flucytosine is being administered
5) Cases with a history of alcohol hypersensitivity
Target sample size 45

Research contact person
Name of lead principal investigator Yoshinobu Iwasaki
Organization Kyoto Prefectural University of Medicine
Division name Department of Pulmonary Medicine
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL 075-251-5513
Email c1981311@koto.kpu-m.ac.jp

Public contact
Name of contact person Yusuke Chihara
Organization Kyoto Prefectural University of Medicine
Division name Department of Pulmonary Medicine
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL 075-251-5513
Homepage URL
Email c1981311@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 02 Month 08 Day

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 11 Month 12 Day
Anticipated trial start date
2011 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 08 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040750

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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