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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004385
Receipt No. R000005217
Scientific Title Prognostic Siginificance of (18)F-Fluorodeoxyglucose Positron Emission Tomography in Patients with Limited Stage Small Cell Lung Cancer
Date of disclosure of the study information 2010/10/14
Last modified on 2011/11/15

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Basic information
Public title Prognostic Siginificance of (18)F-Fluorodeoxyglucose Positron Emission Tomography in Patients with Limited Stage Small Cell Lung Cancer
Acronym Prognostic Siginificance of FDG-PET in Patients with Limited Stage Small Cell Lung Cancer
Scientific Title Prognostic Siginificance of (18)F-Fluorodeoxyglucose Positron Emission Tomography in Patients with Limited Stage Small Cell Lung Cancer
Scientific Title:Acronym Prognostic Siginificance of FDG-PET in Patients with Limited Stage Small Cell Lung Cancer
Region
Japan

Condition
Condition Limited Stage Small Cell Lung Cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Radiology Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the prognostic siginificance of (18)F-fluorodeoxyglucose positron emission tomography in patients with limited-stage small-cell lung cancer who received 4 cycles of etoposide and cisplatin plus early concurrent accelerated hyperfractionated thoracic irradiation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression free survival
Response rate

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 CDDP+VP-16 4 cycles
CDDP 80mg/m2 day1, VP-16 100mg/m2 day1-3
early concurrent twice-daily RT 1.5Gy 30fraction
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
20 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) cytologically, histologically proven small-cell lung cancer
2) limited disease except c-stage I
3) age 20-74 years old
4) performance status of 0-1
5) measurable disease
6) no prior treatment for small-cell lung cancer
7) no history of chemotherapy
8) adequate organ functions
9) written informed consent
Key exclusion criteria 1) pericardial effusion
2) active concomitant malignancy
3) pregnant or lactating women
4) interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukito Ichinose
Organization National Kyushu Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address Fukuoka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Ebi
Organization Iizuka Hospital
Division name Department of respiratory medicine
Zip code
Address
TEL 0948-22-3800
Homepage URL
Email

Sponsor
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization Clinical Research Support Center kyushu
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
2010 Year 10 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2010 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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
2010 Year 10 Month 14 Day
Last modified on
2011 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005217

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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