Prospective Cohort Study of Breast Cancer Patients Treated With Radiotherapy

NCT04203849 | Enrolling By Invitation

• 1 other identifier: NCC2019-0142
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

breast cancer occurred 19,219cases in 2015 and is the second most common cancer among female cancers in the country. despite there's been a disease understanding and treatment developing through study, the prevalence and mortality of breast cancer have increased steadily over the last 15 years. In the last 20 years, through random clinical studies of breast cancer, radiation therapy is well-established standard therapy as postoperative supplement of invasive breast cancer and intraepithelial carcinoma but, the need for further study with new questions about radiation therapy has been raised through these studies. according to the prospective study outcome, the radiation treatment of the regional lymph node in breast cancer patients with lymph node positive increases the free-disease survival rate, radiation therapy for regional lymph node is being actively treated than in the past. on the contrary, the results of another study are being reported that treating regional lymph node may increase the risk of arm edema, radiation pneumonia and heart toxicity. In the recently, due to advancement in radiation therapy technique, the implement of new radiation therapy such as IMRT that reducing radiation dose to normal tissues of the axillary, lungs, heart and others has been actively attempted. additional research is needed on dose-fractionation schedule, regional lymph node treatment, post-treatment toxicity of radiation therapy in breast cancer. this study establishes a prospective cohort at breast cancer patients with radiation treatment and analyze the local and regional lymph node control, recurrence, toxicity, radiation planning, clinical data, discover the factors that predict local control, regional control, overall survival, recurrence-free survival, toxicity for treatment, so we intend to construct basic data that establishes a radiation treatment strategy based on comprehensive outcomes and predictors.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• local and regional lymphnode control, free-recurrence, survival period

  local and regional lymphnode control, free-recurrence, survival period is defined as the date of occurrence or end based of an event on the date of breast cancer diagnosis. the date of occurrence of an event means the progress of local and region lymph node by disease, the recurrence(or progression) of disease or the confirmed date of death and the date of disconnection means the final date on which the event was determined not to have occurred. * In follow up loss, the date on which survival is confirmed before follow up loss is disconnection date. * a cancer diagnosis date is calculated based on the date of radiological examination of the findings.

  up to 6 month

Secondary Outcomes (2)

• therapeutic responses according to image examination

  up to 6 month

• toxicity of radiotherapy

  up to 6 month

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

breast cancer patient

You may qualify if:

• scheduled to be a radiotherapy at National cancer center
• agreed to participate in the study

You may not qualify if:

• \- disagreed to participate in the study

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tae H Kim, Ph.D

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 18, 2019
• Study Start: July 3, 2019
• Primary Completion: June 1, 2022
• Study Completion (Estimated): June 30, 2034
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

KR (1)