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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003330
Receipt No. R000004013
Scientific Title Phase II study of nedaplatin plus irinotecan for stage III/IV squamous cell lung cancer (TORG0910)
Date of disclosure of the study information 2010/03/15
Last modified on 2013/03/13

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Basic information
Public title Phase II study of nedaplatin plus irinotecan for stage III/IV squamous cell lung cancer (TORG0910)
Acronym Phase II study of nedaplatin plus irinotecan for squamous cell lung cancer
Scientific Title Phase II study of nedaplatin plus irinotecan for stage III/IV squamous cell lung cancer (TORG0910)
Scientific Title:Acronym Phase II study of nedaplatin plus irinotecan for squamous cell lung cancer
Region
Japan

Condition
Condition Unresectable stage III/IV and relapsed after resection squamous cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Efficacy and safety of nedaplatin and irinitecan regimen for unresectable squamous cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes overall survival, progression disease free survival, adverse event rate

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 nedaplatin 100mg/m2 (day1) and irinotecan 60mg/m2 (day1,8), every 4-5 weeks, total 4-6 courses
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)Squamous cell lung cancer
2)Unresectable stage III/IV and postoperative relapsed squamous cell lung cancer
3)Chemotherapy naive
4)Target lesion is measurable
5)More than 20 years old, less than 75 years old
6)Expected survival is more than 12 weeks
7)ECOG Performance Status 0-1
8)Adequate hematologic, hepatic, and renal functions.
9)More than 2week rest period after palliative radiation or control of pleural effusion
10)Written informed consent
Key exclusion criteria 1)Massive pleural effusion
2)Massive pericardial effusion
3)double cancer
4)severe complications; myocardial infarction, unstable angina, heart failure, uncontrolled hypertension, ued uncontrolled diabetis mellitus, uncontrolled infection, uncontrolled mental disease, SVC syndrome
5)irinotecan contraindication; watery diarrhea, ileus, digestive organs bleeding, jaundice, bone marrow suppression
6)nedaplatin contraindication; renal failure
7)lung fibrosis
8)pregnancy
9)other inappropriate cases
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouzo Yamada
Organization Kangawa Cancer Center
Division name Thoracic Oncology
Zip code
Address Nakao 1-1-2, Asahiku, Yokohama City
TEL 045-391-5761
Email

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiro Saito
Organization Kanagawa Cancer Center
Division name Thoracic Oncology
Zip code
Address Nakao 1-1-2, Asahiku, Yokohama City
TEL 045-391-5761
Homepage URL
Email saito-h@kcch.jp

Sponsor
Institute Thoracic Oncology Research Group (TORG)
Institute
Department

Funding Source
Organization Thoracic Oncology research Group (TORG)
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 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)
KKR札幌医療センター(北海道)
宮城県がんセンター(宮城県)
東京医科大学病院(東京)
藤沢市民病院(神奈川)
虎ノ門病院(東京)
都立駒込病院(東京)
群馬県立がんセンター(群馬)
千葉大学(千葉)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 15 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 Completed
Date of protocol fixation
2010 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2015 Year 04 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 03 Month 13 Day
Last modified on
2013 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004013

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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