Prospective Cohort Study of Breast Cancer Patients Treated With Radiotherapy
Prospective Cohort Study for Identifying Factors Predicting Clinical Outcomes of Breast Cancer Patients Treated With Radiotherapy
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.
調査の概要
状態
条件
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Gyeonggi
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Goyang、Gyeonggi、大韓民国、410-769
- National Cancer Center Korea
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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local and regional lymphnode control, free-recurrence, survival period
時間枠:up to 6 month
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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.
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up to 6 month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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therapeutic responses according to image examination
時間枠:up to 6 month
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therapeutic responses according to image examination is calculated as the fraction of the subjects who showed either 'CR' or 'PR' according to the RECIST criteria. *Response Criteria (RECIST)
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up to 6 month
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toxicity of radiotherapy
時間枠:up to 6 month
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toxicity is calculated as the fraction of toxicity higher than grade 3 according to CTCAE.
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up to 6 month
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協力者と研究者
捜査官
- 主任研究者:Tae H Kim, Ph.D、National Cancer Center, Korea
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
乳がんの臨床試験
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