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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035773
Receipt No. R000040622
Scientific Title A feasibility study of 1-mm bolus for postmastectomy radiotherapy
Date of disclosure of the study information 2019/07/01
Last modified on 2020/08/19

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Basic information
Public title A feasibility study of 1-mm bolus for postmastectomy radiotherapy
Acronym 1-mm bolus for postmastectomy radiotherapy
Scientific Title A feasibility study of 1-mm bolus for postmastectomy radiotherapy
Scientific Title:Acronym 1-mm bolus for postmastectomy radiotherapy
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to assess the safety of the use of daily 1-mm bolus in patients undergoing postmastectomy radiotherapy by monitored skin toxicity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin toxicity from start of radiotherapy to 12 weeks after completion of radiotherapy
Key secondary outcomes 1. Chest wall recurrences during observation
2. Skin dose using dosimeters within 5 times of beginning radiation

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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients who meet all of the following criteria;
1. Aged 20 years and older
2. Received mastectomy, pathologically confirmed breast cancer, and needed to receive postmastectomy radiotherapy
3. Performance status (ECOG) 0-2
4. Written informed consent
Key exclusion criteria 1. Patients have other concomitant active malignancy except carcinoma in situ.
2. Patients have uncontrolled diabetes.
3. Patients have active interstitial pneumonitis or lung fibrosis or advanced pulmonary emphysema.
4. Patients have active collagen disease.
5. Patients have heart failure, myocardial infarction or angina pectoris within 6 months.
6. Patients have pregnancy or nursing.
7. Patients have psychiatric disorders that may comprise the patient's ability to receive radiotherapy.
8. Patients have breast reconstruction before radiotherapy
9. Patients have prior overlapping radiation.
10. Patients who need to receive boost irradiation for positive surgical margin.
11.Patients who is considered ineligible for enrolling the study by a principal investigator or sub-investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Naoto
Middle name
Last name Shikama
Organization Juntendo University
Division name Department of Radiation Oncology
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email n-shikama@juntendo.ac.jp

Public contact
Name of contact person
1st name Terufumi
Middle name
Last name Kawamoto
Organization Juntendo University
Division name Department of Radiation Oncology
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email t-kawamoto@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
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 Juntendo University
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel 0338133111
Email t-kawamoto@juntendo.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
2019 Year 07 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 19
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 Completed
Date of protocol fixation
2019 Year 05 Month 20 Day
Date of IRB
2019 Year 06 Month 21 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Skin toxicity from start of radiotherapy to 12 weeks after completion of radiotherapy

Management information
Registered date
2019 Year 02 Month 04 Day
Last modified on
2020 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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