UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000358 |
|---|---|
| Receipt number | 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 13:11:57 |
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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
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
hiro@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000455
