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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008821
Receipt No. R000010279
Scientific Title Study of the efficacy and safety of maintenance Irinotecan in patients with extended small cell lung cancer after 4 courses of Cisplatin plus Irinotecan chemotherapy.
Date of disclosure of the study information 2012/08/31
Last modified on 2015/05/15

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Basic information
Public title Study of the efficacy and safety of maintenance Irinotecan in patients with extended small cell lung cancer after 4 courses of Cisplatin plus Irinotecan chemotherapy.
Acronym Maintenance Irinotecan
Scientific Title Study of the efficacy and safety of maintenance Irinotecan in patients with extended small cell lung cancer after 4 courses of Cisplatin plus Irinotecan chemotherapy.
Scientific Title:Acronym Maintenance Irinotecan
Region
Japan

Condition
Condition extended small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of maintenance Irinotecan in patients with extended small cell lung cancer and achieved PR or CR response after 4 courses of Cisplatin plus Irinotecan chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes feasibility at 6 months
Key secondary outcomes overall survival
progression-free survival
response rate
rate of adverse events

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 Four cycles of Cicplatin(60mg/m2 day1)and Irinotecan(60mg/m2 day1, 8,15) followed by maintenance Irinotecan(CPT-11)(60mg/m2 day1, 8,15) until disease progression.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1)Pathologically diagnosed as small cell lung cancer
2)Diagnosed as extended small cell lung cancer based on chest CT, abdominal CT, bone scintigraphy or brain MRI at the onset of disease.
3)Age 20=<,70=>
4)ECOG PS0or1
5)Measurable or nonmeasrurable lesions
6)CR or PR is achieved after the prior chemotherapy of Cisplatin (60mg/m2) and Irinotecan(60mg/m2 day1,8,15) .
7)Administered at least 9 times Irinotecan in prior IP chemotherapy
8)Registered after irradiated PCI, in the case of brain metastasis was not found before the prior chemotherapy. PCI is not always required.
9)Registered after irradiated WBRT(3Gy/Fr total 30Gy) after the prior IP chemotherapy , in the case of brain metastasis was found before the prior chemotherapy. WBRT is required.
10)No history of chemotherapy for other than lung cancer, and radiotherapy or surgery for primary lung cancer.
11)Adequate organ function, evaluated within 14 days before enrollment as;
1.WBC >=3,000/mm3 and Neutrophil >=1,500/mm3
1.Hemoglobin >=9.0 g/dL
3.Platelets >=100,000/mm3
4.Total bilirubin <=2.0mg/mL
5.GOT(AST)<=100 IU/L
6.GPT(ALT)<=100 IU/L
7.Serum creatinine <=1.5 mg/dL
8.PaO2>=70mmHg or SpO2>=95%
9.Normal electrocardiogram
12)Passed 4 weeks and over, under 8 weeks, from the last day of the administration of the IP chemotherapy.
13)Expected to live over 3 months from the first day of the chemotherapy.
14)Written informed consent from the patients.
Key exclusion criteria 1)Active multiple malignacy
2)Grave complications
3)Bacterial infectious or fungus infection
4)Diarrhea
5)Paresis of intestine or ileus
6)Interstitial pneumonia or pulmonary fibrosis on chest CT
7)Dose of Irinotecan in prior chemotherapy is >60 mg/m2 at fourth course
8)Uncontrolled diabetes
9)Grave heart disease
10)Psychological disease decided not to be registered to this study
11)Pregnant or lactating women
12)Gastroduodenal ulcer
13)Grave complications
14)Doctor's decision not to be registered to this study
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Ohe
Organization National Cancer Center Hospital East
Division name Division of Thoracic Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email yohe@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Umemura
Organization National Cancer Center Hospital East
Division name Division of Thoracic Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email sumemura@east.ncc.go.jp

Sponsor
Institute Division of Thoracic Oncology, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization National Cancer Center Research and developing found
Organization
Division
Category of Funding Organization Other
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 国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
がん感染症センター都立駒込病院
癌研究会有明病院
横浜市立市民病院
新潟県立がんセンター新潟病院
兵庫県立がんセンター
近畿大学医学部
岡山大学医学部・歯学部付属病院
国立病院機構山口宇部医療センター
国立病院機構四国がんセンター
国立病院機構九州がんセンター

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 31 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
2012 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 07 Day
Last follow-up date
2015 Year 02 Month 16 Day
Date of closure to data entry
2015 Year 02 Month 16 Day
Date trial data considered complete
2015 Year 02 Month 16 Day
Date analysis concluded
2015 Year 02 Month 16 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 31 Day
Last modified on
2015 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010279

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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