Clinical trial NCT04203849: Prospective Cohort Study of Breast Cancer Patients Treated With Radiotherapy
Official title: Prospective Cohort Study for Identifying Factors Predicting Clinical Outcomes of Breast Cancer Patients Treated With Radiotherapy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2019-12-18
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast cancer patient

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- disagreed to participate in the study

Primary outcomes:
measure: local and regional lymphnode control, free-recurrence, survival period
timeFrame: up to 6 month
Secondary outcomes:
measure: therapeutic responses according to image examination
timeFrame: up to 6 month
measure: toxicity of radiotherapy
timeFrame: up to 6 month
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center Korea
state: Gyeonggi
Study officials:
affiliation: National Cancer Center, Korea
name: Tae H Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: