UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000436 |
|---|---|
| Receipt number | 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 | 2021/02/17 16:47:07 |
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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
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
sfujita@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
IVAN Investigators
Institute
Department
Personal name
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
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
| 2006 | Year | 06 | Month | 01 | Day |
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
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 06 | Month | 23 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000530
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