UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014815 |
|---|---|
| Receipt number | R000017225 |
| Scientific Title | A pilot study on the safety and the efficacy of dose escalation in stereotactic body radiotherapy for the lung tumor |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2018/02/11 09:50:50 |
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Basic information
Public title
A pilot study on the safety and the efficacy of dose escalation in stereotactic body radiotherapy for the lung tumor
Acronym
Dose escalation study in stereotactic body radiotherapy for the lung tumor
Scientific Title
A pilot study on the safety and the efficacy of dose escalation in stereotactic body radiotherapy for the lung tumor
Scientific Title:Acronym
Dose escalation study in stereotactic body radiotherapy for the lung tumor
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and the efficacy of the dose escalation in stereotactic body radiotherapy for the lung tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of adverse effect
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Dose escalation in radiotherapy
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) Primary or metastatic lung cancer
A. Primary lung cancer;
Tumor size </=5cm, and clinical stage IA or IB
B. Metastatic lung cancer;
Tumor size </=5cm, two lung lesions or less, and no lesions other than lung
2) Those who are inoperable or who refuse surgery
3) Dose to adjacent organ is not estimated to exceed constraints in pretreatment chest CT
4) Patients' age must be>/=20 years old
5) ECOG performance status must be 0-2
6) Patients can lay on their back holding their arms over the heads, and keep that position at least 30 minutes
Key exclusion criteria
1) previous irradiation around the lesion
2) With active interstitial pneumonia or pulmonary fibrosis
3) With severe diabetic mellitus or collagen disease
4) Women during pregnancy or lactating , or who might be pregnant
5) With psychiatric illness which impede protocol treatment
6) Patients who are considered to be inappropriate for this study by physicians
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukinori Matsuo |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
Address
54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL
075-751-3762
ymastuo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamasa Mitsuyoshi |
Organization
Kyoto University Hospital
Division name
Department of Radiation Therapy
Zip code
Address
54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL
075-751-3762
Homepage URL
mitsu.t@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 10 | Day |
Last modified on
| 2018 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017225
