UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049536
Receipt number R000056404
Scientific Title Questionnaire exploring patients' enthusiasm for ultrahypofractionated postoperative radiation therapy following breast conservation surgery
Date of disclosure of the study information 2022/12/01
Last modified on 2023/07/07 00:25:59

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Basic information

Public title

Questionnaire exploring patients' enthusiasm for ultrahypofractionated postoperative radiation therapy following breast conservation surgery

Acronym

QUATTRO study

Scientific Title

Questionnaire exploring patients' enthusiasm for ultrahypofractionated postoperative radiation therapy following breast conservation surgery

Scientific Title:Acronym

QUATTRO study

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To explore patient's needs for ultrahypofractionated radiotherapy following breast conservation surgery in patients with breast cancer.

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Patient's needs for ultrahypofractionated radiotherapy following breast conservation surgery.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

Female

Key inclusion criteria

Breast cancer patients undergoing postoperative radiation therapy with mild hypofractionation or standard fractionation regimen following breast conservation surgery

Key exclusion criteria

Patients undergoing accelerated partial breast radiation therapy, ultrahypofractionated regimen, or regional nodal irradiation

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Haruka
Middle name
Last name Uezono

Organization

Hyogo Cancer Center

Division name

Department of Radiation Oncology

Zip code

673-8558

Address

13-70 Kitaoji-Cho, Akashi

TEL

0789291151

Email

haru770911@yahoo.co.jp


Public contact

Name of contact person

1st name haruka
Middle name
Last name uezono

Organization

Hyogo Cancer Center

Division name

Department of Radiation Oncology

Zip code

673-8558

Address

13-70 Kitaoji-Cho, Akashi

TEL

0789291151

Homepage URL


Email

haru770911@yahoo.co.jp


Sponsor or person

Institute

Hyogo Cancer Center, Department of Radiation Oncology

Institute

Department

Personal name



Funding Source

Organization

National Cancer Center Research Development Fund

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

hyogo cancer center

Address

13-70 Kitaoji-Cho, Akashi

Tel

0789291151

Email

haru770911@yahoo.co.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

2022 Year 12 Month 01 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

No longer recruiting

Date of protocol fixation

2022 Year 10 Month 16 Day

Date of IRB

2022 Year 10 Month 31 Day

Anticipated trial start date

2022 Year 11 Month 01 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 09 Month 30 Day


Other

Other related information

Data will be collected regarding the patients' role within the family and the society. We will obtain patients' sense of value regarding the treatment period and the risk of long-term toxicity from ultrahypofractionated radiotherapy.


Management information

Registered date

2022 Year 11 Month 16 Day

Last modified on

2023 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056404


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name