UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006682
Receipt No. R000007896
Scientific Title Early prediction of survival to gefitinib or chemotherapy using integrated FDG-PET for patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2011/11/08
Last modified on 2011/11/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Early prediction of survival to gefitinib or chemotherapy using integrated FDG-PET for patients with advanced non-small cell lung cancer
Acronym PET trial
Scientific Title Early prediction of survival to gefitinib or chemotherapy using integrated FDG-PET for patients with advanced non-small cell lung cancer
Scientific Title:Acronym PET trial
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to assess the integrated 18-fluorodeoxyglucose positron emission tomography (FDG-PET) at 3 day after treatment as a tool for early response predictor in patients treated with gefitinib or carboplatin plus paclitaxel (CP) prospectively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FDG-PET was performed before and 3 day after initiation of each treatment. Based on previous studies, a reduction of tumor FDG uptake was assessed by using standardized uptake value (SUV).
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 PET examination
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The main eligibility criterion was pathologically confirmed stage IIIB or IV NSCLC. Additional criteria were as follows: (1) Eastern Cooperative Oncology Group performance status from 0 to 2, (2) bidimensionally measurable lesion(s) on FDG-PET and CT scans, (3) no prior chemotherapy or prior molecular-targeted therapy.
Key exclusion criteria The patients with uncontrolled diabetes mellitus, defined as fasting blood glucose higher than 150 mg/dl, were excluded.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Takada
Organization Kinki University Sakai Hospital
Division name Medical Oncology
Zip code
Address 2-7-2 Harayamadai, Minami-ku, Sakai, Osaka591-0132, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Kanazu
Organization Kinki-chuo Chest Medical Center
Division name Internal Medicine
Zip code
Address
TEL
Homepage URL
Email kanamasa@kch.hosp.go.jp

Sponsor
Institute Kinki-chuo Chest Medical Center
Institute
Department

Funding Source
Organization Foundation for intractable diseases
Organization
Division
Category of Funding Organization Non profit foundation
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
2011 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
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
2007 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 07 Day
Last modified on
2011 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.