UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003330 |
|---|---|
| Receipt number | 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 14:52:48 |
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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
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
saito-h@kcch.jp
Sponsor or person
Institute
Thoracic Oncology Research Group (TORG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004013
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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