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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000535
Receipt No. R000000648
Scientific Title Prospective study of wide excision and endocrine therapy WithOut RadioTHerapy (WORTH) for node-negative estrogen receptor positive early breast cancer with histologically negative margins (WORTH trial)(No.3)
Date of disclosure of the study information 2006/12/10
Last modified on 2019/12/16

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Basic information
Public title Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for node-negative estrogen receptor positive early
breast cancer with histologically negative margins (WORTH trial)(No.3)
Acronym Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for early breast cancer (WORTH trial)(No.3)
Scientific Title Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for node-negative estrogen receptor positive early
breast cancer with histologically negative margins (WORTH trial)(No.3)
Scientific Title:Acronym Prospective study of wide excision and endocrine therapy WithOut
RadioTHerapy (WORTH) for early breast cancer (WORTH trial)(No.3)
Region
Japan

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

Objectives
Narrative objectives1 Our aim of this trial is to determine in-breast recurrence rate in the patients who experience breast-conserving surgery, do not have all the factors which were shown to be risk factors for in-breast recurrence after breast-conserving treatment including radiotherapy in the retrospective study, and do not receive radiotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes In-breast recurrence rate
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 tamoxifen
complete tumor resection
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
40 years-old <=
Age-upper limit
49 years-old >=
Gender Female
Key inclusion criteria 1. tumor size is 3 cm or smaller on palpation
2. pathologically axillary node negative (or no metastasis in sentinel node(s) if only sentinel node biopsy was done) and no distant metastasis or a case of ductal carcinoma in situ
3. No preoperative treatments including chemotherapy, endocrine therapy and radiotherapy
4. 40 to 49 years old at definitive surgery
5. a tumor was resected with wide local excision and the pathological margins were negative (tumor cells must be absent in the zone of 5mm or more from the margins)
6. no pathological findings of lymph vessel invasion
7. estrogen receptor positive in the primary tumor
8. within 8 weeks after the definitive surgery
9. a written informed consent was obtained
Key exclusion criteria 1. multicentricity of the tumor is suspected
2. past history of breast cancer or synchronous bilateral breast cancer
3. trastuzumab treatment is planned
4. the patient has mental disorder
5. any reason the physician believes that the patient is not appropriate to participate in the study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shozo
Middle name
Last name Shozo
Organization National Hospital Organization Shikoku Cancer Center
Division name Breast Oncology
Zip code 791-0280
Address 160 Kou, Minamiumemotomachi, Matsuyama, Ehime
TEL 089-999-1111
Email sosumi@shikoku-cc.go.jp

Public contact
Name of contact person
1st name Shozo
Middle name
Last name Ohsumi
Organization National Hospital Organization Shikoku Cancer Center
Division name Breast Oncology
Zip code 791-0280
Address 160 Kou, Minamiumemotomachi, Matsuyama, Ehime
TEL 089-999-1111
Homepage URL
Email sosumi@shikoku-cc.go.jp

Sponsor
Institute a Grant-in-Aid for research of cancer treatment from the Ministry of Health, Labor and Welfare of Japan (No.17-7)
Institute
Department

Funding Source
Organization a Grant-in-Aid for research of cancer treatment from the Ministry of Health, Labor and Welfare of Japan (No.21-7-4)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NHO Shikoku Cancer Center
Address 160 Kou, Minami-umemoto-machi, Matsuyama, Japan
Tel 089-999-1111
Email 089-999-1100

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 四国がんセンター(愛媛県)、大阪府立成人病センター(大阪府)、熊本市民病院(熊本県)、大阪医療センター(大阪府)、国立がん研究センター中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2006 Year 12 Month 10 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
2006 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2006 Year 12 Month 01 Day
Last follow-up date
2022 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 12 Month 02 Day
Last modified on
2019 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000648

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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