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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000113
Receipt No. R000000166
Scientific Title phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
Date of disclosure of the study information 2005/09/05
Last modified on 2016/09/27

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Basic information
Public title phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
Acronym phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
Scientific Title phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
Scientific Title:Acronym phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
Region
Japan

Condition
Condition extensive disease small-cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to evaluate the efficacy and safety of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Primary endpoint: response rate. Secondary endpoints: overall survival, time to progression, and toxicity.
Key secondary outcomes

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 single-arm phse II study. Patients receive irinotecan 60 mg/m2 intravenously on day 1 and 8 plus cisplatin 60 mg/m2 intravenously on day 1 every three weeks for three cycle, then amrubicin 40 mg/m2 intravenously on day 1 to 3 every three weeks for three cycle.
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) small-cell lung cancer; 2) extensive disease; 3) Eastern Cooperative Oncology Group performance status of 0 or 1; 4) age of 20 to 70 years; 5) no prior chemotherapy; 6) neither palliative radiation nor surgery within 14 days; 7) measurable lesions; 8) a life expectancy of at least two months; 9) adequate organ fanctions; and 10) written informed consent.
Key exclusion criteria 1) symptomatic brain metastases; 2) pleural or pericardial effusion requiring drainage; 3) interstitial pneumonitis or pulmonary fibrosis; 4) active infection; 5) watery diarrhea, paralysis of the intestine, or ileus; 6) active gastric or duodenal ulcer; 7) continuous administration of steroids or non-steroidal anti-inflammatory drugs; 8) uncontrolled diabetes mellitus or angina pectoris; 9) active concomitant malignancies; 10) a history of serious drug allergy; 11) pregnancy or lactation; and 12) unsuitable for entry to the study, decided by a medical oncologist.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name aoru Matsui (head), Masashi Kobayashi (secretariat)
Organization Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name Department of Thoracic Malignancy
Zip code
Address 3-7-1 Habikino, Habikino-shi, Osaka 583-8588, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed?term=20479694
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
2004 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2004 Year 09 Month 01 Day
Last follow-up date
2008 Year 10 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
2005 Year 09 Month 05 Day
Last modified on
2016 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000166

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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