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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN C000000205
Receipt No. R000000271
Scientific Title Randomized comparative study of cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer (OLCSG 0403)
Date of disclosure of the study information 2005/09/13
Last modified on 2015/01/08

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Basic information
Public title Randomized comparative study of cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer (OLCSG 0403)
Acronym cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer
Scientific Title Randomized comparative study of cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer (OLCSG 0403)
Scientific Title:Acronym cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer
Region
Japan

Condition
Condition Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This is a randomized Phase III study comparing cisplatin, docetaxel and irinotecan combination to cisplatin and docetaxel for the treatment of stage IIIB or stage IV non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Quality of life
Key secondary outcomes Best overall response
Duration of overall response
Time to progression
Adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention arm: Cisplatin (60mg/m2, day1), Docetaxel (60mg/m2, day 1), Irinotecan (60mg/m2, day 2) combination chemotherapy
Interventions/Control_2 Control arm: Cisplatin (80mg/m2, day1), Docetaxel (60mg/m2, day 1) combination chemotherapy
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

Not applicable
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histologically and/or cytologically proven NSCLC
2. No prior treatment
3. Age<=70
4. stage IIIB, or IV
5. ECOG performance status: 0-1
6. Measurable or evaluable disease
7. Adequate bone marrow function: WBC>=4,000/cmm and PLT>=100,000/cmm
8. Adequate liver function: T-Bil<=1.5 mg/dl, GOT, GPT<=2.5 x normal value
9. Adequate renal function: Creatinine<1.5 mg/dl and Ccr>=60 ml/min
10. Adequate pulmonary function: PaO2>=60 Torr (room air, at rest)
11. Written informed consent
Key exclusion criteria 1. Symptomatic brain metastasis
2. Active concomittant malignancy, history of previous chemotherapy or thoracic radiation therapy for malignancy
3. Clinically significant allergic history
4. Pregnant or lactating women
5. Severe comrbidities
1) Active interstial pneumonia
2) Unstable angina pectoris, or recent history of myocardial infarction
3) Uncntrolled diabetes mellitus
4) Sever active infection
5) Pleural effusion or ascites which require treatment
6) Clinically significant pericardial effusion
7) Other clinical condition which is considered as inappropriate for this study
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsune Tanimoto
Organization Okayama University Hospital
Division name Department of Hematology, Oncology and Respiratory Medicine
Zip code
Address 2-5-1 Shikatacho, Okayama 700-8558, Japan
TEL 086-235-7227
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Tabata
Organization Okayama Lung Cancer Study Group Coordinating Office
Division name Department of Hematology, Oncology and Respiratory Medicine, Okayama University Hospital
Zip code
Address 2-5-1 Shikatacho, Okayama 700-8558, Japan
TEL 086-235-7227
Homepage URL
Email tabata@md.okayama-u.ac.jp

Sponsor
Institute Okayama Lung Cancer Study Group (OLCSG)
Institute
Department

Funding Source
Organization N/A
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 13 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 Main results already published
Date of protocol fixation
2004 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2004 Year 03 Month 01 Day
Last follow-up date
2011 Year 12 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 13 Day
Last modified on
2015 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000271

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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