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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000358
Receipt No. R000000455
Scientific Title A Phase II study of induction chemotherapy S-1 and CDDP in patients with FDG-PET positive N2 disease of non-small cell lung cancer.
Date of disclosure of the study information 2006/04/01
Last modified on 2006/09/20

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Basic information
Public title A Phase II study of induction chemotherapy S-1 and CDDP in patients with FDG-PET positive N2 disease of non-small cell lung cancer.
Acronym Induction therapy for N2 positive NSCLC
Scientific Title A Phase II study of induction chemotherapy S-1 and CDDP in patients with FDG-PET positive N2 disease of non-small cell lung cancer.
Scientific Title:Acronym Induction therapy for N2 positive NSCLC
Region
Japan

Condition
Condition Non small cell lung cancer
Classification by specialty
Chest surgery Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of induction chemotherapy for node positive non small cell lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes adverse event, over all survival, recurrence-free survival rate, effectiveness of evaluation by PET scan

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 Chemotherapy
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 cytological proved non-small cell lung cancer.
2. Performance status of 0 or 1
3.PET positive mediastinal node positive c-stage IIIA
4.Adequate bone marrow reserve, hepatic, renal functions, and normal cardiac function
5.Written informed consent is required to obtain from each patient at each participating institution
Key exclusion criteria 1. active interstitial pneumonia
2. active infectious disease
3. active other cancer
4. severe drug allergy
5. severe complications
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Suzuki
Organization Fukushima Medical University
Division name Department of Surgery 1
Zip code
Address 960-12951 Hikarigaoka Fukushima, Fukushima
TEL 024-547-1254
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Suzuki
Organization Fukushima Medical University
Division name Department of Surgery 1
Zip code
Address 960-12951 Hikarigaoka Fukushima, Fukushima
TEL 024-547-1254
Homepage URL http://www.fmu.ac.jp/home/surgery1/FLAG/index2.htm
Email hiro@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Fukushima Red cross hospitalIwaki public hospitalSouthern Tohoku general hospitalYonezawa city hospitalSirakawa kosei hospital
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
2006 Year 04 Month 01 Day

Related information
URL releasing protocol http://www.fmu.ac.jp/home/surgery1/FLAG/index2.htm
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
Date of protocol fixation
2005 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2010 Year 12 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
2006 Year 03 Month 13 Day
Last modified on
2006 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000455

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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