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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001494
Receipt No. R000001799
Scientific Title Phase III Study of adjuvant chemotherapy for the patients resected pathological stage I(T1>2cm) Non Small Cell Lung Cancer (JCOG0707)
Date of disclosure of the study information 2008/11/10
Last modified on 2014/03/05

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Basic information
Public title Phase III Study of adjuvant chemotherapy for the patients resected pathological stage I(T1>2cm) Non Small Cell Lung Cancer (JCOG0707)
Acronym Phase III Study of adjuvant chemotherapy for the patients resected pathological stage I(T1>2cm) Non Small Cell Lung Cancer (JCOG0707)
Scientific Title Phase III Study of adjuvant chemotherapy for the patients resected pathological stage I(T1>2cm) Non Small Cell Lung Cancer (JCOG0707)
Scientific Title:Acronym Phase III Study of adjuvant chemotherapy for the patients resected pathological stage I(T1>2cm) Non Small Cell Lung Cancer (JCOG0707)
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 estimate the efficacy of TS-1 compared to UFT as the post operative adjuvant chemotherapy for completely resected pathological stage I (T1>2cm) non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes relapse free survival
Key secondary outcomes Overall Survival, pattern of recurrence, treatment completion rate, adverse events, severe adverse events, second malignancy, compliance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: UFT for 2 years
Interventions/Control_2 B: TS-1 for 1 year
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 I (T1>2cm)
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) adequate organ function
9) 20-80 years
10) within 56 days after surgery
11) Signed informed consent
Key exclusion criteria 1) Active another neoplasm
2) severe postoperative complications
3) severe complications
4) history of severe hypersensitivity(>=Grade3)
5) Concomitant therapy with flucytocine, phenytoin or Warfarin Potassium
6) pregnant or lactating women
7) serious psychiatric illness
8) HIV positive
Target sample size 960

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Tsuboi
Organization Yokohama City University Medical Center
Division name Chest surgery
Zip code
Address 4-57, Urafunetyo, Minami-ku, Yokohama, Kanagawa 232-0024, JAPAN
TEL 045-261-5656
Email mtsuboi@za2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Kunitoh / Hiroyuki Sakurai
Organization JCOG0707 Coordinating Office
Division name Division of Chemotherapy, Japanese Red Cross Medical Center/Division of Thoracic Surgery, NCC Hosp
Zip code
Address 4-1-22 Hiroo,Shibuya-ku,Tokyo 150-0012, Japan / 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL 03-3400-1311.03-3542-2511
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 国立病院機構仙台医療センター(宮城県)
東北大学病院(宮城県)
山形県立中央病院(山形県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
群馬県立がんセンター(群馬県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
千葉大学医学部(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京医科大学病院(東京都)
がん・感染症センター都立駒込病院(東京都)
がん研究会有明病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
聖マリアンナ医科大学(神奈川県)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
金沢大学医学部(石川県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
名古屋大学医学部(愛知県)
京都大学医学部附属病院(京都府)
大阪大学医学部(大阪府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
大阪府立病院機構大阪府立呼吸器・アレルギー医療センター(大阪府)
国立病院機構近畿中央胸部疾患センター(大阪府)
大阪市立総合医療センター(大阪府)
兵庫県立がんセンター(兵庫県)
倉敷中央病院(岡山県)
岡山大学病院(岡山県)
国立病院機構呉医療センター・中国がんセンター(広島県)
広島大学病院(広島県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
長崎大学病院(長崎県)
熊本大学医学部(熊本県)
熊本中央病院(熊本県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2008 Year 11 Month 10 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 No longer recruiting
Date of protocol fixation
2008 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 10 Day
Last follow-up date
2018 Year 11 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 11 Month 10 Day
Last modified on
2014 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001799

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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