UMIN-CTR Clinical Trial

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
Email	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
Email	k-ishi@med.kindai.ac.jp

Sponsor
Institute	Kindai University
Institute
Department

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)
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033965