UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035773 |
|---|---|
| Receipt number | 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 19:28:31 |
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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
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
t-kawamoto@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040622
