UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004100 |
|---|---|
| Receipt number | R000004932 |
| Scientific Title | Phase I study of stereotactic body radiation therapy (SBRT) for stage IA, centrally located non-small cell lung cancer |
| Date of disclosure of the study information | 2010/08/25 |
| Last modified on | 2017/08/30 12:54:39 |
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Basic information
Public title
Phase I study of stereotactic body radiation therapy (SBRT) for stage IA, centrally located non-small cell lung cancer
Acronym
Phase I study of SBRT for stage IA, centrally located non-small cell lung cancer
Scientific Title
Phase I study of stereotactic body radiation therapy (SBRT) for stage IA, centrally located non-small cell lung cancer
Scientific Title:Acronym
Phase I study of SBRT for stage IA, centrally located non-small cell lung cancer
Region
| Japan |
Condition
Condition
stage IA non-small cell lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum tolerated dose (MTD) and recommended dose of stereotactic body radiation therapy (SBRT) for medically inoperable or surgery-refused stage IA, centrally located non-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
Rates ofadverse events other than a dose-limiting toxicity (DLT) which is possibly, or definitely related to treatment and which occurs within 1 year from the start of SBRT.
Key secondary outcomes
Rates of treatment completion, incidence of late adverse effects which occurs after 1 year from the start of SBRT, the 3-year local control, recurrence of out pf field, and overall survival rates.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Level1;52Gy/8fr, 6.5Gy/fr
Interventions/Control_2
Level2;62Gy/8fr, 7Gy/fr
Interventions/Control_3
Level3;60Gy/8fr, 7.5Gy/fr
Interventions/Control_4
Level4;64Gy/8fr, 8Gy/fr
Interventions/Control_5
Level5;68Gy/8fr, 8.5Gy/fr
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Pathologically proven diagnosis of non-small cell lung cancer(NSCLC).
2)Diagnosed stage T1a or T1bN0M0 by imaging including CT within 35 days, FDG-PET within 60 days.
3) medically inoperable or refuse surgery
4)Tumor within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree(carina, right and left main bronchi, right and
left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi). Tumors that are immediately adjacent to mediastinal or pericardial pleura also are considered central tumors and are eligible for this protocol.
5)Keep dose constraints
6)PaO2>60torr/mmHg or FEV1.0>700ml
7) No prior treatment for NSCLC
8)Age;20>, 85<
9)Eastern Cooperative Oncology Group (ECOG) performance status 0-2
10) informed consent
Key exclusion criteria
1) Prior invasive malignancy unless disease free for a minimum of 3 years (e.g., carcinomas in situ, T1N0M0 laryngeal cancer, low risk prostate cancer;T1-2a and Gleason score 2-6 an dPSA < 10 ng/ml, stage I breast, and cancers which can expect long survalval as well as these cancers are permissible)
2)Prior radiotherapy to the region of the study cancer that would result in overlap of radiationtherapy fields;
3) Obvious interstitial pnumonitis or fibrosis on chest X-ray
4) Active infection
5)Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study
6) patients who are judged to be imppsible to participate this study due to psycologic disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoki Kimura |
Organization
Hiroshima University Hospital
Division name
Radiation Oncology
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima City
TEL
082-257-1545
tkkimura@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoki Kimura |
Organization
Hiroshima University Hospital
Division name
Radiation Oncology
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima City
TEL
082-257-1545
Homepage URL
http://home.hiroshima-u.ac.jp/housya/
tkkimura@hiroshima-u.ac.jp
Sponsor or person
Institute
Japanese Radiation Oncology Study Group(JROSG)
Institute
Department
Personal name
Funding Source
Organization
Japanese Radiation Oncology Study Group(JROSG)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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 | 08 | Month | 25 | Day |
Related information
URL releasing protocol
http://www.jrosg.jp/
Publication of results
Published
Result
URL related to results and publications
http://www.jrosg.jp/
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
| 2010 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 25 | Day |
Last modified on
| 2017 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004932
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/08/30 | JROSG10-1_DOI_10.1007_s10147-017-1125-y.pdf |
