UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017780 |
|---|---|
| Receipt number | R000020049 |
| Scientific Title | Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study |
| Date of disclosure of the study information | 2015/06/06 |
| Last modified on | 2021/05/20 13:41:30 |
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Basic information
Public title
Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
Acronym
A feasibikity study of IMRT for locally advanced NSCLC
Scientific Title
Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
Scientific Title:Acronym
A feasibikity study of IMRT for locally advanced NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A feasibility of chemoradiotherapy using IMRT for locally advanced NSCLC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The ratio of the patients who completed chemoradiotherapy using IMRT
Key secondary outcomes
safety, progression free survival, overall survival, first relapse site
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
Chemotherapy and IMRT
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed NSCLC
2) Inoperable
3) Stage III NSCLC patients who are suitable for definitive RT
4) No previous chemotherapy and thoracic radiotherapy
5) Who have measurable lesions
6) Age 20-74 years old
7) Performance status 0,1
8) Who are able to eat by oral intake
9) Who are without severe co-morbid conditions
10) Informed consent
Key exclusion criteria
1)Active double cancer
2)History of severe infections or complications
3)HBs antigen positive
4)History of thoracic radiotherapy
5)Radiographically (chest CT image) confirmed interstitial pneumonitis or pulmonary fibrosis
6)Severe emphysema, chronic bronchitis, asthma
7)History of drug-induced pneumonia or severe drug allergies
8)Uncontrolled diabetes despite continuing treatment of insulin
9)Unstable angina, cardiac infarction within 6 months before enrollment
10)A fever of over 38 degrees
11)Continuous systemic administration of steroid or immunosuppressant
12)Pregnant women
13)Patients with severe mental illness
14)Unsuitable patients judged by the attending physician
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Harada |
Organization
Shizuoka Cancer Center
Division name
Radiation Oncology
Zip code
Address
1007 shimonagakubo, nagaizumi, Shizuoka.
TEL
81559895222
h.harada@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Harada |
Organization
Shizuoka Cancer Center
Division name
Radiation Oncology
Zip code
Address
1007 shimonagakubo, nagaizumi, Shizuoka
TEL
81559895222
Homepage URL
h.harada@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Local Government
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
静岡がんセンター（静岡県）近畿大学（大阪府）大阪府済生会中津病院（大阪府）先端医療センター（兵庫県）広島大学（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 06 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 02 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020049
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| Registered date | File name |
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