UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005911 |
|---|---|
| Receipt number | R000006990 |
| Scientific Title | Phase I study for dose escalation in limited small cell lung cancer |
| Date of disclosure of the study information | 2011/07/02 |
| Last modified on | 2018/07/07 13:18:38 |
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Basic information
Public title
Phase I study for dose escalation in limited small cell lung cancer
Acronym
Phase I study for dose escalation in limited small cell lung cancer
Scientific Title
Phase I study for dose escalation in limited small cell lung cancer
Scientific Title:Acronym
Phase I study for dose escalation in limited small cell lung cancer
Region
| Japan |
Condition
Condition
Limited small cell lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of dose escalation in radiotherapy in limited small cell lung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Acute toxicity G3 or more
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
3DCRT:Radiotherapy
Arm 1:48Gy1.5 Gyb.i.d./22d
Arm 2:54Gy1/24d
Arm 3:60Gy/4wks=26d
Arm 4:66Gy32d
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologically diagnosed as a limited NSCLC
2) Fresh case
3) ECOG PD 0-1
4) Wtitten informed consent
Key exclusion criteria
1) Uncontrollable DM
2) Collagen disease
3) Concurrent cancer with activity
4) Pregnant
5) Elonging treatment time
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideya Yamazaki |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Radiology
Zip code
Address
465 Kajiicho Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566 Japan
TEL
075-251-5111
yamahi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | office |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
IRB
Zip code
Address
465 Kajiicho Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566 Japan
TEL
075-251-5111
Homepage URL
rinri@koto.kpu-m.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
京都府立医科大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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 | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006990
