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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000120
Receipt No. R000000178
Scientific Title Randomized phase II study of irinotecan and cisplatin or irinotecan, cisplatin and etoposide in patients with extensive small-cell lung cancer
Date of disclosure of the study information 2006/06/01
Last modified on 2008/03/12

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Basic information
Public title Randomized phase II study of irinotecan and cisplatin or irinotecan, cisplatin and etoposide in patients with extensive small-cell lung cancer
Acronym Randomized phase II study of IP vs IPE for E-SCLC
Scientific Title Randomized phase II study of irinotecan and cisplatin or irinotecan, cisplatin and etoposide in patients with extensive small-cell lung cancer
Scientific Title:Acronym Randomized phase II study of IP vs IPE for E-SCLC
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy and safety of irinotecan and cisplatin therapy and irinotecan, cisplatin and etoposide therapy for extensive small-cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes median survival time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cisplatin 60 mg/m2 day 1 and irinotecan 60 mg/m2 days 1 and 8 were administered every 3 weeks for four cycles.
Interventions/Control_2 Cisplatin 60 mg/m2 day 1, irinotecan 60 mg/m2 days 1 and 8 and etoposide 50 mg/m2 days 1-3 were administered every 3 weeks for four cycles with prophylactic granulocyte colony-stimulating factor support.
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) a histological or cytological diagnosis of SCLC; 2) no prior treatment; 3) measurable disease; 4) extensive disease, defined as having distant metastasis or contralateral hilar lymph node metastasis; 5) performance status of 0 to 2; 6) predicted life expectancy of 3 months; 7) adequate organ function as documented by a WBC count 4,000/micro L, neutrophil count 2,000/ micro L, hemoglobin 9.5 g/dl, platelet count 100,000/ micro L, total serum bilirubin 1.5 mg/dl, hepatic transaminases 100 IU/l, serum creatinine 1.2 mg/dl, creatinine clearance 60 ml/min, and PaO2 60 Torr; and 8) written informed consent.
Key exclusion criteria 1) uncontrollable pleural, pericardial effusion or ascites; 2) symptomatic brain metastasis; 3) active infection;4) contraindications for the use of irinotecan, including diarrhea, ileus, interstitial pneumonitis and lung fibrosis; 5) synchronous active malignancies; 6) serious concomitant medical illness, including severe heart disease, uncontrollable diabetes mellitus or hypertension; or 7) pregnancy or breast feeding.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohide Tamura
Organization National Cancer Center Hospital
Division name Division of Medical Oncology
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ikuo Sekine
Organization Lung Cancer Study Group
Division name Division of Medical Oncology, National Cancer Center Hospital
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email isekine@ncc.go.jp

Sponsor
Institute Division of Medical Oncology, National Cancer Center Hospital
Institute
Department

Funding Source
Organization Division of Policy-Based Medical Service Planning, National Cancer Center
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2006 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2002 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2002 Year 03 Month 01 Day
Last follow-up date
2006 Year 12 Month 01 Day
Date of closure to data entry
2006 Year 12 Month 01 Day
Date trial data considered complete
2006 Year 12 Month 01 Day
Date analysis concluded
2006 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 06 Day
Last modified on
2008 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000178

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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