UMIN-CTR Clinical Trial

Public title

Establishment of adaptive radiotherapy by deformable image registration using planning-CT and cone-beam CT

Acronym

Establishment of adaptive radiotherapy by deformable image registration using planning-CT and cone-beam CT

Scientific Title

Establishment of adaptive radiotherapy by deformable image registration using planning-CT and cone-beam CT

Scientific Title:Acronym

Establishment of adaptive radiotherapy by deformable image registration using planning-CT and cone-beam CT

Region

Japan

Condition

Head and neck cancer, prostate cancers, lung cancer, liver cancer, cervical cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate deformable image registration using planning-CT and cone-beam CT for adaptive radiotherapy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

This study compares dose distribution with CT and CBCT. We evaluate the clinical efficacy of this method based on these results.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

We use imaging data collected for IGRT during treatment, such as cone beam CT. Therefore, it is non-invasive study.

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

Age-lower limit

20

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients scheduled to be treated with image guided radiotherapy at our facility are selected.

Key exclusion criteria

Except above condition.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Noriko Kotoura

Organization

Hyogo College of Medicine College Hospital

Division name

Department of Radiological Technology

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya-shi, Hyogo, Japan

TEL

0798-45-6259

Email

rt4562@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Masao Tanooka

Organization

Hyogo College of Medicine College Hospital

Division name

Department of Radiological Technology

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya-shi, Hyogo, Japan

TEL

0798-45-6259

Homepage URL

http://www.hyo-med.ac.jp/department/radd/page0103.html

Email

tanooka@hyo-med.ac.jp

Institute

Hyogo College of Medicine

Institute

Department

Personal name

Organization

Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

https://www.scirp.org/journal/PaperInformation.aspx?PaperID=73421

Number of participants that the trial has enrolled

Results

Deformable image registration (DIR) has been an important component in adaptive radiotherapy (ART). Our goal was to examine the accuracy of ART using the dice similarity coefficient (DSC) and to determine the optimal timing of replanning. A total of 22 patients who underwent volume modulated arc therapy (VMAT) for head and neck (H&N) cancers were prospectively analyzed. The planning target volume (PTV) was to receive a total of 70 Gy in 33 fractions. A second planning CT scan (rescan) was performed at the 15th fraction. The DSC was calculated for each structure on both CT scans. The continuous variables to predict the need for replanning were assessed. The optimal cut-off value was determined using receiver operating characteristic (ROC) curve analysis. In the correlation between body weight loss and DSC of each structure, weight loss correlated negatively with DSC of the whole face (rs = -0.45) and the face surface (rs = -0.51). Patients who required replanning tended to have experienced rapid weight loss. The threshold DSC was 0.98 and 0.60 in the whole face and the face surface, respectively. Patients who showed low DSC in the whole face and the face surface required replanning at a significantly high rate (P < 0.05 and P < 0.01). Weight loss correlated with DSC in both the whole face and the face surface (P < 0.05 and P < 0.05). The DSC values in the face predicted the need for replanning. In addition, weight loss tended to correlate with DSC. DIR during ART was found to be a useful tool for replanning.

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

01

Month

20

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

20

Day

Last follow-up date

2017

Year

12

Month

14

Day

Date of closure to data entry

2017

Year

12

Month

14

Day

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

12

Month

14

Day

Last modified on

2017

Year

12

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029064