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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005416
Receipt No. R000006426
Scientific Title Induction chemoradiotherapy with cisplatin plus vinorelbine and irradiation, followed by surgery in cT1-3N2M0, stage IIIA non-small cell lung cancer.
Date of disclosure of the study information 2011/05/01
Last modified on 2011/11/09

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Basic information
Public title Induction chemoradiotherapy with cisplatin plus vinorelbine and irradiation, followed by surgery in cT1-3N2M0, stage IIIA non-small cell lung cancer.
Acronym CDDP/VNR/RT and surgery for pN2 NSCLC
Scientific Title Induction chemoradiotherapy with cisplatin plus vinorelbine and irradiation, followed by surgery in cT1-3N2M0, stage IIIA non-small cell lung cancer.
Scientific Title:Acronym CDDP/VNR/RT and surgery for pN2 NSCLC
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to analyze the efficacy and safety of induction chemotherapy with cisplatin and vinorelbine and irradiation, followed by resection in pathologically proven pN2-IIIA non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes 3-yr recurrent-free survival, efficacy, percentage of accomplish surgical resection, percentage of adverse effects and severe adverse effects of the treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 induction chemoradiotherapy and surgery
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 Resectable cN2-IIIA NSCLC
ECOG PS 0-1
Having measurable tumor
First treatment for the NSCLC
Neutrophil >= 1,500/mm3
Hemoglobin >= 10 g/dL
Platelet >= 100,000/mm3
GOT, GPT =< 2 * UNL
s-Cre =< 1/5 mg/dL
Written informed consent
Key exclusion criteria Synchronous / metachronous double cancer
without in-situ carcinoma.
History of chest irradiation
Current severe infection
Severe cardiac and/or pulmonary diseases
Severe diabetes merritus
Steroid users
Female in pregnancy
Patients who is evaluated as "not suitable" for clinical trial by practitioners
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Date
Organization Kyoto University Hospital
Division name Department of Thoracic Surgery
Zip code
Address Shogoin Kawara-cho 54, Sakyo-ku, Kyoto Citiy
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Sonobe
Organization Kyoto University Hospital
Division name Department of Thoracic Surgery
Zip code
Address Shogoin Kawara-cho 54, Sakyo-ku, Kyoto Citiy
TEL
Homepage URL
Email msonobe-ths@umin.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Grant pool for research in department of thoracic surgery, Kyoto University Hospital
Organization
Division
Category of Funding Organization Self funding
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 01 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 Enrolling by invitation
Date of protocol fixation
2011 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2019 Year 05 Month 01 Day
Date of closure to data entry
2019 Year 05 Month 01 Day
Date trial data considered complete
2019 Year 06 Month 01 Day
Date analysis concluded
2019 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 09 Day
Last modified on
2011 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006426

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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