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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010189
Receipt No. R000011933
Scientific Title A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Date of disclosure of the study information 2013/03/07
Last modified on 2018/11/09

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Basic information
Public title A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Acronym A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Scientific Title A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Scientific Title:Acronym A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to examine the efficacy and safety of combination chemotherapy with S-1 and carboplatin in advanced and recurence non-small lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Overall survival,
Progression free survival
1-year survival Rate,
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 CBDCA AUC:5 d1 q4w until PD
TS-1 was administered at fixed dose based on the body surface area(BSA) of the patient.
BSA<1.25 m2 80mg/day
BSA 1.25-1.5 m2 100mg/day
BSA>1.5 m2 120mg/day
d1-14 q4w until PD
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 (1)Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer
(2)Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery
(3)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors
(4) Age:20-74years old
(5)ECOG performance status of 0 to 1
(6)With ability of oral intake
(7)Adequate organ function, evaluated within 14 days before enrollment
(8)Expected to live over 3 months after administration days.
(9)Written informed consent from the patients.
Key exclusion criteria 1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray
2)Patients with pleural or pericardial effusion ,or ascites
3) Patients with active double cancer
4)Patients with significant complications
a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months
b)Uncontrolled diabetes or hypertension
c)Current severe infection, or suspicious of severe infection
d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella)
5)Patients with symptomatic brain metastasis
6)Patients with pregnancy or lactation
7) History of serious drug allergy
8) History of serious allergic reaction with CBDCA or other platinum-containing drug
9) History of serious allergic reaction with S-1
10) Being treated with other pyrimidine fluoride antineoplastic agents.
11) Being treated with flucytosine.
12) Any patients judged by the investigator to be unfit to participate in the study

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name ogawara mitsumasa
Organization National Hospital Organization Osaka
Division name Department of Respiratory Medicine
Zip code
Address 2-1-14 Hoenzaka, Chou-ku, Osaka 540-0006, Japan
TEL 06-6942-1331
Email ogawaram@onh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name ogawara mitsumasa
Organization National Hospital Organization Osaka
Division name Department of Respiratory Medicine
Zip code
Address 2-1-14 Hoenzaka, Chou-ku, Osaka 540-0006, Japan
TEL 06-6942-1331
Homepage URL
Email ogawaram@onh.go.jp

Sponsor
Institute National Hospital Organization Osaka
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2013 Year 03 Month 07 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
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 Completed
Date of protocol fixation
2013 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 07 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011933

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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