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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000436
Receipt No. R000000530
Scientific Title A phase II study of Iressa and vinorelbine/gemcitabine in chemo-naive elderly patients with advanced non-small-cell lung cancer screened for EGFR mutation status.
Date of disclosure of the study information 2006/06/23
Last modified on 2018/09/30

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Basic information
Public title A phase II study of Iressa and vinorelbine/gemcitabine in chemo-naive elderly patients with advanced non-small-cell lung cancer screened for EGFR mutation status.
Acronym IVAN Trial
Scientific Title A phase II study of Iressa and vinorelbine/gemcitabine in chemo-naive elderly patients with advanced non-small-cell lung cancer screened for EGFR mutation status.
Scientific Title:Acronym IVAN Trial
Region
Japan

Condition
Condition Non-small-cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate the clinical value of pre-treatment screening of epidermal growth factor receptor (EGFR) mutation in tumors. On the basis of the results of mutation analysis, elderly chemo-naive patients are treated with either gefitinib or cytotoxic drug (vinorelbine or gemcitabine). Response rate and other clinical outcomes will be assessed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients whose tumor has an EGFR mutation are treated with gefitinib.
Interventions/Control_2 Patients whose tumor has a wild-type EGFR are treated with vinorelbine or gemcitabine.
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Histologically confirmed non-small-cell lung cancer
2.Adequate biopsy sample for EGFR mutation analysis
3.Stage IIIB or IV disease unsuitable for curative radiotherapy
4.Age of 70 or older
5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6.Adequate organ function
7.Written informed consent was obtained
Key exclusion criteria 1.Symptomatic brain metastasis
2.Patients who received previous chemotherapy
3.Overt interstitial pneumonia in chest CT
Target sample size 88

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Mio
Organization Kyoto University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 54 Shogoin Kawaracho, Sakyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shiro Fujita
Organization Kyoto University Hospital
Division name Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Email sfujita@kuhp.kyoto-u.ac.jp

Sponsor
Institute IVAN Investigators
Institute
Department

Funding Source
Organization Kyoto University Hospital
Organization
Division
Category of Funding Organization
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
2006 Year 06 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://bmccancer.biomedcentral.com/articles/10.1186/1471-2407-12-185
Number of participants that the trial has enrolled
Results
Characteristics of the 54 eligible patients enrolled from July 2006 to April 2009 included median age of 80 years (range, 71-89 years); 20 men; 29 never smokers; and 37 with adenocarcinoma. Response was 45% in patients with EGFR mutations and 19% in patients without EGFR mutations. Median overall survival was 24.4 months in patients with EGFR mutations, while it is 18.9 months in patients without EGFR mutations. In the gefitinib group, grade 3/4 hepatic dysfunction occurred in 23%; dermatitis, in 5%. In patients treated with vinorelbine or gemcitabine, the most common grade 3 or 4 adverse events were neutropenia (47%; 4 had febrile neutropenia), anorexia (9%), anemia (6%), nausea (6%) and fatigue (6%). No treatment-related death occurred.
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
2006 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 06 Month 23 Day
Last modified on
2018 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000530

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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