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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000087
Receipt No. R000000138
Scientific Title To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
Date of disclosure of the study information 2005/08/29
Last modified on 2015/08/31

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Basic information
Public title To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
Acronym To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
Scientific Title To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
Scientific Title:Acronym To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
Region
Japan

Condition
Condition unresectable stage III NSCLC
Classification by specialty
Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 arm A : The chemotherapy regimen consist of Cisplatin 80mg/m2 on day1 AND 29, Vindesine 3mg/m2 on day1,8, 29, and 36, Mitomycin 8mg/m2 on day1 and 29. The concurrent radiation consists of two, 30 gray courses separated by a 7-day rest period. Patients receive 2 courses of chemotherapy consist of Cisplatin, Vindesine, and Mitomycin as consolidation chemotherapy.
Interventions/Control_2 arm B: The chemotherapy regimen consists of Irinotecan 20mg/m2 and Carboplatin AUC2 administered weekly for 6 weeks. The concurrent radiation consists of 60 gray. Patients receive 2 courses of chemotherapy consist of Irinotecan and Carboplatin as consolidation chemotherapy.
Interventions/Control_3 arm C: The chemotherapy regimen consists of Paclitaxel 40mg/m2 and Carboplatin AUC2 administered weekly for 6 weeks. The concurrent radiation consists of 60 gray. Patients receive 2 courses of chemotherapy consist of Paclitaxel and Carboplatin as consolidation chemotherapy.
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
75 years-old >
Gender Male and Female
Key inclusion criteria All patients had histologocally or cytologically confirmed locally advanced NSCLC. All patients must not have undergone any previous therapy for NSCLC. Patients had to have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and to be less than 75 years old. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.
Key exclusion criteria The exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection.
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Uejima
Organization Rinku General Medical center
Division name Department of Pulmonary Medicine
Zip code
Address 2-23, Rinku-Orai-Kita, Izumisano, Osaka 598-8577, Japan
TEL 0724-69-3111
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 2-23, Rinku-Orai-Kita, Izumisano, Osaka 598-8577, Japan
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 08 Month 29 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=20625120
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
2001 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2001 Year 10 Month 01 Day
Last follow-up date
2006 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 29 Day
Last modified on
2015 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000138

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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