UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003622 |
|---|---|
| Receipt number | R000004389 |
| Scientific Title | A phase II study of nedaplatin plus irinotecan for stage III/IV and EGFR mutation negative non-small cell lung cancer with high-risk factors |
| Date of disclosure of the study information | 2010/05/18 |
| Last modified on | 2015/01/07 16:02:06 |
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Basic information
Public title
A phase II study of nedaplatin plus irinotecan for stage III/IV and EGFR mutation negative non-small cell lung cancer with high-risk factors
Acronym
A phase II study of nedaplatin plus irinotecan for stage III/IV NSCLC with high-risk factors
Scientific Title
A phase II study of nedaplatin plus irinotecan for stage III/IV and EGFR mutation negative non-small cell lung cancer with high-risk factors
Scientific Title:Acronym
A phase II study of nedaplatin plus irinotecan for stage III/IV NSCLC with high-risk factors
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of efficacy and safety about nedaplatin plus irinotecan therapy for stage III/IV and EGFR mutation negative non-small cell lung cancer with high-risk factors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Frequency of adverse events, progression free survival and over all survival
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 50 mg/m2(days 1, 8)+Irinotecan hydrochloride 50 mg/m2(days 1, 8) 4-5 weeks interval, total 1-4 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)histologically or cytologically confirmed non-small cell lung cancer
2)unresectable, stage III or IV disease and radical radiotherapy unable
3)possess measurable lesion
4)EGFR mutation negative (wild type)
5)20 years old or over
6)naive to chemotherapy or radiotherapy, but recurrence after surgery case is eligible
7)written informed consent
and applicable to 1 or 2 risk factors below
1)ECOG Perfomance status 2
2)70 years old or over
3)white blood cell count; 3,000/mm3 or over, or less than 4,000/mm3
4)absolute neutrophil count; 1,500/mm3 or over, or less than 2,000/mm3
5)hemoglobin; 9.0 g/dL or over, or less than 10.0 g/dL
6)platelet count; 75,000/mm3 or over, or less than 100,000/mm3
7)serum total bilirubin; over within normal limits but less than 1.5 mg/dL
8)AST/ALT; over within normal limits but less than 100 IU/L
9)serum creatinine; over within normal limits but less than 1.5 mg/dL
10)symptomatic brain or osseous metastasis
Key exclusion criteria
1)applicable over 2 risk factors above
2)ECOG Perfomance Status; 3 or 4
3)white blood cell count; less than 3,000/mm3
4)absolute neutrophil count; less than 1,500/mm3
5)hemoglobin; less than 9.0 g/dL
6)platelet count; less than 75,000/mm3
7)serum total bilirubin; 2.0 mg/dL or over
8)AST/ALT; 100 IU/L or over
9)serum creatinine; 1.5 mg/dL or over
10)pleural effusion(eligible for difficult puncture case or cytologically negative and clinically ignorable case)
11)evident pericardial effusion
12)serious complications below
I)uncontrollable angina pectoris, myocardial infarction within 6 months or heart failure
II)serious heart dosease
III)uncontrollable diabetes or hypertension
IV)infection
13)applicable for contraindication of nedaplatin
I)serious myelosuppression
II)serious renal failure
14)applicable for contraindication of irinotecan hydrochloride
I)existing diarrhea (watery diarrhea)
II)existing bowel paralysis or bowel obstructuction
III)existing fresh bleeding of GI tract
IV)existing jaundice
V)existing myelosuppression
15)pulmonary fibrosis or interstitial pneumonitis evident on chest X ray
16)now pregnant or lactation, or possible pregnancy or refusal of contraception
17)difficult to perform or continue of this study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouzo Yamada |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
1-1-2, Nakao, Asahi-ku, Yokohama, Japan
TEL
045-391-5761
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuro Kondo |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
1-1-2, Nakao, Asahi-ku, Yokohama, Japan
TEL
045-391-5761
Homepage URL
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 18 | 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 | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 16 | Day |
Last modified on
| 2015 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004389
