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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000097
Receipt No. R000000146
Scientific Title A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2005/08/31
Last modified on 2015/08/31

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Basic information
Public title A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer
Acronym A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer
Scientific Title A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer
Scientific Title:Acronym A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer
Region
Japan

Condition
Condition ECOG PS2 patients with advanced non-small cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of carboplatin and paclitaxel versus gemcitabine and vinorelbine in PS2 patients with advanced NSCLC in a randomized phase II study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes One-year survival rate
Key secondary outcomes Response rate, time to progression, safety,QOL

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 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carboplatin and paclitaxel
Interventions/Control_2 Gemcitabine and vinorelbine
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically or cytologically proven NSCLC with no prior chemotherapy
2. Stage IIIB with malignant pleural or pericardial effusion, stage IV, or recurrent disease after prior surgery or radiotherapy
3. Measurable or evaluable disease;
4. ECOG performance status of 2
5. Life expectancy ≥3 months
6. Age ≥18 years
7. Adequate baseline organ function:
Neutrophile ≥1,500/mm3; platelet count ≥100,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤5 times of the institutional upper limit; total bilirubin ≤1.5 mg/dl; serum creatinine ≤1.5 mg/dl or 24-hour creatinine clearance ≥60 ml/min
8. Signed informed consent

Key exclusion criteria 1. Prior radiotherapy to evaluable disease unless subsequent progression at that site
2. Prior brain metastases if not clinically stable after surgery and/or radiotherapy
3. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <6 months before enrollment or congestive heart failure
4. Active concomitant malignancy requiring treatment.
5. Uncontrolled serious active infection
6. Pre-existing grade 2 neuropathy
7. Pregnancy or lactation
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Saito, M.D.
Organization Aichi Cancer Center Aichi Hospital
Division name Department of Respiratory Medicine
Zip code
Address 18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan.
TEL 0564-21-6251
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 18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, 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 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21293243
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 04 Month 14 Day
Date of IRB
Anticipated trial start date
2001 Year 07 Month 01 Day
Last follow-up date
2006 Year 09 Month 01 Day
Date of closure to data entry
2007 Year 04 Month 01 Day
Date trial data considered complete
2007 Year 04 Month 01 Day
Date analysis concluded
2007 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 31 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=R000000146

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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