Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer

NCT ID: NCT03568981

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-11

Study Completion Date

2023-04-11

Brief Summary

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This study aim to investigate the effect of 5-fraction stereotactic partial breast irradiation and whole breast irradiation on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis in early-stage breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Partial Breast Irradiation (PBI)

Patients receiving 5-fraction stereotactic partial breast irradiation for breast cancer

Partial breast irradiation

Intervention Type RADIATION

After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.

Whole Breast Irradiation (WBI)

Patients receiving whole breast irradiation for breast cancer

Whole breast irradiation

Intervention Type RADIATION

After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.

Interventions

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Partial breast irradiation

After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.

Intervention Type RADIATION

Whole breast irradiation

After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS)
* Women who underwent breast-conservating surgery and have a plan to undergoing partial or whole breast irradiation
* Good performance status (ECOG 0-1)

Exclusion Criteria

* Recurrent breast cancer
* History of ipsilateral breast irradiation
* Positive resection margin status after breast surgery
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Korea, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong Bae Kim, MD, PhD

Role: CONTACT

82-2228-8095

Facility Contacts

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YongBae Kim, MD

Role: primary

82-10-6256-2592

References

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Byun HK, Chang JS, Kim H, Kim J, Han MC, Kim SY, Park RH, Kim CJ, Kim YB. Cosmetic Outcome and Toxicity After Stereotactic Accelerated Partial Breast Irradiation in Early Breast Cancer: A Prospective Observational Cohort Study. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):690-700. doi: 10.1016/j.ijrobp.2023.05.018. Epub 2023 May 17.

Reference Type DERIVED
PMID: 37201757 (View on PubMed)

Other Identifiers

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4-2018-0160

Identifier Type: -

Identifier Source: org_study_id

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