UMIN-CTR Clinical Trial

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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