UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005585 |
|---|---|
| Receipt number | R000006512 |
| Scientific Title | Dose-escalation study of proton beam therapy with chemotherapy for locally advanced non-small lung cancer |
| Date of disclosure of the study information | 2011/05/12 |
| Last modified on | 2016/04/23 21:43:47 |
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Basic information
Public title
Dose-escalation study of proton beam therapy with chemotherapy for locally advanced non-small lung cancer
Acronym
Proton beam therapy dose escalation for NSCLC
Scientific Title
Dose-escalation study of proton beam therapy with chemotherapy for locally advanced non-small lung cancer
Scientific Title:Acronym
Proton beam therapy dose escalation for NSCLC
Region
| Japan |
Condition
Condition
Unresectable Non-small Lung Cancer
Classification by specialty
| Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To define the recommended dose of proton beam therapy concurrent with chemotherapy for unresectable non-small lung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To determine maximum torrelated dose and recommended dose
Key secondary outcomes
Adverse event
Tumor response
survival 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 | Device,equipment |
Interventions/Control_1
Proton beam therapy 66-74 GyE
(Cisplatin 60mg/m2 + TS-1 40mg d1-d4)
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
| 27 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Histologically proven Non-small lung cancer, Stage IIIA-IIIB
ECOG PS 0-1
Tumor size was measured by 4 wks before registration
Good organ function
Key exclusion criteria
Drug allergy
Active infection
Lymph node metastasis at contra-lateral hiller, supraclavicular region. P
Severe complication
Apparent interstitial pneumonitis
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fuji |
Organization
Shizuoka Cancer Center
Division name
Division of Proton therapy
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Shizuoka-pref.
TEL
055-989-5222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fuji |
Organization
Shizuoka Cancer Center
Division name
Division of Proton therapy
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Shizuoka-pref.
TEL
055-989-5222
Homepage URL
h.fuji@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 12 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 11 | Day |
Last modified on
| 2016 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006512
