UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004385 |
|---|---|
| Receipt number | 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 14:55:58 |
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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
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
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005217
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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