UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001721 |
|---|---|
| Receipt number | R000002057 |
| Scientific Title | Prospective phase II study of stereotactic body radiation therapy using helical tomotherapy for stage IA non-small cell lung cancer. |
| Date of disclosure of the study information | 2009/02/20 |
| Last modified on | 2018/02/26 19:11:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective phase II study of stereotactic body radiation therapy using helical tomotherapy for stage IA non-small cell lung cancer.
Acronym
SBRT with helical tomotherapy for lung cancer
Scientific Title
Prospective phase II study of stereotactic body radiation therapy using helical tomotherapy for stage IA non-small cell lung cancer.
Scientific Title:Acronym
SBRT with helical tomotherapy for 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 assess clinical feasibility of stereotactic body radiation therapy with helical tomotherapy for stage IA lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
3-year overall survival rate
Key secondary outcomes
overall survival time, relapse-free survival time, local pregression-free survival time, 3-year local progression free rate, type of recurrence, acute adverse event, late adverse event, ratio of severe adverse event
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
| Device,equipment |
Interventions/Control_1
patient number 50, accrual 4 years, follow-up 3years
stereotactic body radiation therapy 60Gy/6fraction/8-12 days
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
histologically confirmed
stage IA
no mediastinal lymph node metastasis
no previously radiotherapy history
Performance status 0-2
medically unresectable or refuse of surgery
written, informed consent
Key exclusion criteria
interstitial pneumonitis, lung fibrosis
active infection
active multiple cancer (last 3 years)
pregnancy or breast feeding
psychological disorder
systemic steroid medication
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kodaira |
Organization
Aichi Cancer Center Hospital
Division name
Department of Therapeutic Radiation Oncology
Zip code
Address
1-1 Kanoko-den, Chikusa-ku 464-8681, Nagoya, Aichi
TEL
052-762-6111
109103@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuo Tomita |
Organization
Aichi Cancer Center Hospital
Division name
Department of Therapeutic Radiation Oncology
Zip code
Address
1-1 Kanoko-den, Chikusa-ku 464-8681, Nagoya, Aichi
TEL
052-762-6111
Homepage URL
ntomita@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 02 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002057
