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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004100
Receipt No. 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

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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
Email 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/
Email tkkimura@hiroshima-u.ac.jp

Sponsor
Institute Japanese Radiation Oncology Study Group(JROSG)
Institute
Department

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
Email

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
URL(English) https://upload.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


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