UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000205 |
|---|---|
| Receipt number | 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 18:19:34 |
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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
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
tabata@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama Lung Cancer Study Group (OLCSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000271
