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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001779
Receipt No. R000002144
Scientific Title Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809)
Date of disclosure of the study information 2009/04/01
Last modified on 2016/09/21

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Basic information
Public title Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809)
Acronym TS-1 after surgery with CDDP+Docetaxel for p-stage II/IIIA NSCLC(TORG0809)
Scientific Title Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809)
Scientific Title:Acronym TS-1 after surgery with CDDP+Docetaxel for p-stage II/IIIA NSCLC(TORG0809)
Region
Japan

Condition
Condition Non-small Cell Lung Cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of TS-1 after surgery with Cisplatin+Docetaxel for completely resected pathological stage II/IIIA non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes treatment completion proportion
Key secondary outcomes overall survival, relapse free survival, pattern of recurrence, adverse events

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 After CDDP 80mg/m2 + Docetaxel 60mg/m2, day 1 q3-4w, 3 courses, TS-1 80mg/m2 b.i.d., day 1-14 q3w, more than 6 months, maximum 1 year
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) pathologically proven Non-small Cell Lung Cancer
2) pathological stage II, IIIA
3) complete resection
4) at least lobectomy
5) LN dissection (ND2a) or Elective Lymph Node Dissection
6) no prior anti cancer treatment for thoracic malignancy except for this operation
7) ECOG PS 0-1
8) more than 20 years of age, under 75 years of age
9) adequate organ function
10) within 10 weeks after surgery
11) signed informed consent
Key exclusion criteria 1) not recovered from surgical complications
2) active infection such as bacterial infection
3) patients with interstitial pneumonaitis or pulmonary fibrosis, as determined by chest CT
4) patients with myocardial infraction within 6 months
5) patinets with uncontroled complications
6) grade 2 or greater peripheral neuropathy
7) active concomitant malignancy
8) pregnant or lactating woman
9) past history of allergic reactions to polysorbate 80
10) concomitant therapy with flucytocine
11) pneumonectomy
12) other conditions not suitable for this study
Target sample size 125

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiko Ikeda
Organization Tokyo Medical University
Division name Department of Thoracic Surgery
Zip code
Address 6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023, JAPAN
TEL 03-3351-6141
Email ikeda@wd5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Niho
Organization National Cancer Center Hospital East
Division name Thoracic Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa Chiba 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email siniho@east.ncc.go.jp

Sponsor
Institute Thoracic Oncology Research Group (TORG)
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
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
2009 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2009 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 17 Day
Last modified on
2016 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002144

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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