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Recruitment status Terminated
Unique ID issued by UMIN UMIN000003223
Receipt No. R000003786
Scientific Title Feasibility study of UFT after surgery with platinum based adjuvant chemotherapy in completely resected pathological stage II/IIIA non-small cell lung cancer
Date of disclosure of the study information 2010/02/22
Last modified on 2013/09/24

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Basic information
Public title Feasibility study of UFT after surgery with platinum based adjuvant chemotherapy in completely resected pathological stage II/IIIA non-small cell lung cancer
Acronym Platinum based adjuvant chemotherapy followed by maintenance UFT in non-small cell lung cancer
Scientific Title Feasibility study of UFT after surgery with platinum based adjuvant chemotherapy in completely resected pathological stage II/IIIA non-small cell lung cancer
Scientific Title:Acronym Platinum based adjuvant chemotherapy followed by maintenance UFT in non-small cell lung cancer
Region
Japan

Condition
Condition completely resected pathological stage II/IIIA non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility study of UFT after surgery with platinum based in 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 Feasibility, relative performance
Key secondary outcomes relapse-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 Platinum based adjuvant chemotherapy followed by maintenance UFT for 2 years. UFT is administered orally at 320mg/m2/day for 2 years consecutive day.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Pathologically-proven non-small cell lung cancer
2) pathological stage II,IIIA
3) completely resected NSCLC
4) completely resected by at least lobectomy
5) LN dissection (ND2a) or Elective Lymph Node Dissection
6) Without previous therapy for non-small cell lung cancer
7) PS 0 or 1
8) age 20-80
9) adequate organ function
WBC >=4,000/mm3 and <=12,000/mm3
neutrophil >=2,000/mm3
Hb >=10.0g/dl
Plt >=100,000/mm3
T-bil <=1.2mg/dl
AST/ALT <=100IU/L
Ccr >=60mL/min(Cockcroft-Gault)
PaO2 >=70mmHg or SpO2 >=95%
10) possible to receive platinumu based chemotherapy within 10 weeks after surgery
11) written 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) patients with uncontroled complications
6) grade 2 or greater peripheral neuropathy
7) Active another neoplasm
8) pregnant or lactating women
9) concomitant therapy with other fluoropyrimmidine
10) pneumonectomy
11) Patient who is judged to be inappropriate as subject to this study by the principal investigator
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Mochizuki
Organization St.Marianna University School of Medicine
Division name Division of Chest Surgery
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
TEL 044-977-8111
Email a2mochi@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Mochizuki
Organization St.Marianna University School of Medicine
Division name Division of Chest Surgery
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
TEL 044-977-8111
Homepage URL
Email a2mochi@marianna-u.ac.jp

Sponsor
Institute Department of Surgery, Division of Chest Surgery, St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 聖マリアンナ医科大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 22 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 Terminated
Date of protocol fixation
2010 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2017 Year 02 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
2010 Year 02 Month 21 Day
Last modified on
2013 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003786

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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