UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029724 |
|---|---|
| Receipt number | R000033965 |
| Scientific Title | Prospective study on adaptive radiotherapy using treatment room CT |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2022/04/30 14:35:12 |
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Basic information
Public title
Prospective study on adaptive radiotherapy using treatment room CT
Acronym
Prospective study on adaptive radiotherapy using treatment room CT
Scientific Title
Prospective study on adaptive radiotherapy using treatment room CT
Scientific Title:Acronym
Prospective study on adaptive radiotherapy using treatment room CT
Region
| Japan |
Condition
Condition
Pharyngeal & Laryngeal cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this clinical trial, the treatment room CT of radiotherapy patients is deformed on Eclipse, the volumetric change and the position change amount of the target and the risk organs are measured, the dose change is confirmed, and the optimal timing of the re-treatment plan is measured It is aimed at.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Timing at which dose change occurs in treatment room CT (week number)
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
| Device,equipment |
Interventions/Control_1
We will shoot by expanding the shooting range in the treatment room CT not to the conventional 16 cm, but to 32 cm including the entire irradiation range.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with pharyngeal / laryngeal cancer with diagnosis of malignant tumor by histopathological examination
2) Patients who undergo radical chemoradiotherapy or radiotherapy alone (60-70 Gy / 30-35 fractions) to the macroscopic tumor volume of the primary tumor
3) Performance status (ECOG): 0 to 2
4) Patients whose age at registration is 20 years or over, 80 years old or younger
5) About participation in the study Informed consent is obtained from the patient himself.
Key exclusion criteria
1) Patients with radiation therapy alone
2) Patients judged inappropriate by the attending physician
3) Patients who took only less than five shots from the treatment cen- tory CT in the treatment room.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Nishimura |
Organization
Kindai University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
ynishi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kinndai University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
k-ishi@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine Ethics Committee
Address
377-2, Osaka-sayama, Osaka, Japan
Tel
072-366-0221 (ext. 3756)
zizen@med.kinda.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
30
Results
Although volume and dose changes in IMRT for head and neck cancers tend to be consistent, they vary from case to case and require an individualized retreatment plan.
Results date posted
| 2020 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gender: 21 males, 5 females.
Age 40-75 (64 in the center)
Total line 66-70Gy Central value 70Gy (66Gy for NEC, 70Gy for other 29 cases).
PS0 :1 :2 = 23 :2 :1
Participant flow
Consent was obtained from 30 patients with head and neck cancer treated with chemoradiotherapy using two-step method IMRT.
Twenty-six patients had mCBCT taken and were available for analysis.
Adverse events
There is nothing to report.
Outcome measures
The percent change in target and risk organ volumes and dose at week 1 as a reference (100%) was assessed by a paired T-test.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033965
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