UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041875 |
|---|---|
| Receipt number | R000047424 |
| Scientific Title | A phase II study of Simultaneous integrated boost intensity modulated radiotherapy using volumetric modulated arc therapy for locally advanced lung cancers and thoracic malignancies |
| Date of disclosure of the study information | 2021/02/28 |
| Last modified on | 2021/10/13 23:15:37 |
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Basic information
Public title
A phase II study of Simultaneous integrated boost intensity modulated radiotherapy using volumetric modulated arc therapy for locally advanced lung cancers and thoracic malignancies
Acronym
Simultaneous integrated boost intensity modulated radiotherapy using volumetric modulated arc therapy for locally advanced lung cancers and thoracic malignancies
Scientific Title
A phase II study of Simultaneous integrated boost intensity modulated radiotherapy using volumetric modulated arc therapy for locally advanced lung cancers and thoracic malignancies
Scientific Title:Acronym
Simultaneous integrated boost intensity modulated radiotherapy using volumetric modulated arc therapy for locally advanced lung cancers and thoracic malignancies
Region
| Japan |
Condition
Condition
Locally advanced non-small cell lung cancer, post-operative recurrence of non-small cell lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of volumetric modulated arc therapy (VMAT) for locally advanced non-small cell lung cancer and post-operative recurrence of non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival rate at three years after radiation therapy
Key secondary outcomes
the progression free survival at three years after radiation therapy, the incidence and degree of radiation pneumonitis,
relationship between radiation pneumonitis and dosimetric factors
the incidence of adverse effects
the validity of re-treatment planning using the DIR software, the validity of adoptive radiation therapy with cone beam CT, determining the optimal re-planning period, the influence of the changes of body contour for the accuracy of IMRT
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
| Other |
Interventions/Control_1
Patients recieved SIB-IMRT using VMAT, and total dose was 69Gy and 51Gy in 30 fractions for gross tumor and elective lymph node.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) pathologically proven clinical stage-II or III non-small cell lung cancer, or loco-regional recurrence after surgery or chemotherapy,
2) non-surgical candidate,
3) no distant metastasis
4) aged 20 or over,
5) performance status: 0 or 1,
6) A written informed consent was obtained
Key exclusion criteria
1) history of thoracic irradiation
2) with uncontrollable co-morbidity
3) with other active double primary cancer
4) with interstitial pneumonitis or pulmonary fibrosis
5) in pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Yamakado |
Organization
Hyogo College of Medicine
Division name
Department of Radiology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nshinomiya, Hyogo, Japan
TEL
0798-45-6362
ko-yamakado@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Fujiwara |
Organization
Hyogo College of Medicine
Division name
Department of Radiology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nshinomiya, Hyogo, Japan
TEL
0798-45-6362
Homepage URL
m-fuji@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
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
Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nshinomiya, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.ac.jp
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
兵庫医科大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
52
Results
Radiation pneumonitis developed in 38 patients (76%, 38/50), and grade >=2 radiation pneumonitis developed in 11 patients (22%, 11/50). The percentage of lung volume that received a dose in excess of 5 Gy (V5), V10, V20, V30, and the mean lung dose (MLD) in the bilateral and ipsilateral lung were significantly associated with the development of grade >=2 radiation pneumonitis.
Results date posted
| 2021 | Year | 10 | Month | 13 | Day |
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 23 | Day |
Last modified on
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047424
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