UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004796 |
|---|---|
| Receipt number | R000005709 |
| Scientific Title | Phase II Study of cisplatin plus irinotecan for large cell neuroendocrine carcinoma |
| Date of disclosure of the study information | 2010/12/27 |
| Last modified on | 2014/01/10 17:46:37 |
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Basic information
Public title
Phase II Study of cisplatin plus irinotecan for large cell neuroendocrine carcinoma
Acronym
Phase II Study of cisplatin plus irinotecan for large cell neuroendocrine carcinoma
Scientific Title
Phase II Study of cisplatin plus irinotecan for large cell neuroendocrine carcinoma
Scientific Title:Acronym
Phase II Study of cisplatin plus irinotecan for large cell neuroendocrine carcinoma
Region
| Japan |
Condition
Condition
Large cell neuroendocrine carcinoma
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety in cisplatin plus irinotecan for large cell neuroendocrine carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
overall survival, progression free survival, adverse event
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
cisplatin 6mg/m2, day1
irinotecan 6mg/m2, day1, day8, day15
every 4 weeks
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) recurrent disease after surgery or unresectable large cell neuroendocrine carcinoma which is histologically confirmed
2) age:20-75 years old
3) performance status (ECOG performance status score)0-1
4) measurable lesion
5) no prior chemotherapy with platinum-based or irinotecan regimen
6) adequate organ function:
.WBC>=4000/mm3
.Hemoglobin>=9.5g/dL
.Platelet count >=100000/mm3
.Total serum bilirubin<=1.5mg/dL
.GOT, GPT<100IU/L
.Serum creatinine<=1.5mg/dL
.PaO2>=65mmHg
7) written informed consent
8) survival period is expected to be more than 3 months
Key exclusion criteria
1) unresectable disease with indication for chest radiotherapy
2) uncontrolled pleural/pericardial effusion
3) active concomitant malignancy
4) interstitial pneumonia or pulmonary fibrosis as determined by chest x-ray
5) watery diarrhea
6) intestinal obstruction or paralysis
7) symptomatic brain metastasis
8) severe complications:
.uncontrolled angina, myocardial infarction within the previous 3 months, severe cardiac failure
9) pregnant or lactating women
10) psychological disease deemed unacceptable for inclusion to the study
11) severe drug allergy
12) doctor's decision not to be registered to this study
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanji Nagai |
Organization
National Cancer Research Center Hospital East
Division name
Thoracic Oncology Division
Zip code
Address
6-5-1, Kashiwanoha Kashiwa, Chiba, Japan
TEL
04-7133-1111
knagai@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Niho |
Organization
National Cancer Research Center Hospital East
Division name
Thoracic Oncology Division
Zip code
Address
6-5-1, Kashiwanoha Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
siniho@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Research Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
a grant in aid for Cancer research from the Ministry of Health and Welfare, Japan.
Organization
Division
Category of Funding Organization
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 | 12 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2004 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 27 | Day |
Last modified on
| 2014 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005709
