Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery
2019年1月30日 更新者：Yu Tang、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase II Trial of Hypofractionated Whole-breast Radiation and Concomitant Boost to the Surgical Bed After Breast Conserving Surgery
This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.
調査の概要
詳細な説明
OBJECTIVES:
Primary:
To determine the toxicity with adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost (SIB) in women with early breast cancer after breast conserving surgery.
Secondary:
To determine the short term cosmetic and quality of life of the participants treated with this regimen.
To determine the local control of the participants treated with this regimen.
OUTLINE: Patients undergo adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost once daily a week for 3 weeks. Toxicity, quality of life and cosmetic result is assessed before radiation, at the end of the radiation, within 2, 4, 6 weeks after completion of radiotherapy, and then every 3 months for 1 ear.
PROJECTED ACCRUAL: A total of 90 participants will be accrued for this study.
研究の種類
介入
入学 (実際)
90
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Beijing
-
Beijing、Beijing、中国、100021
- National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- female, aged between 18-70
- pathological confirmed breast invasive carcinoma
- patients after breast lumpectomy(including quadrantectomy) with axillary lymph nodes dissection or sentinel node biopsy
- stage p T 1-2 N 0
- metastasis omitted by routine examinations in 1 months before enrollment
- complete blood count obtained in 2 weeks prior to study entry should meet the following criteria: absolute neutrophil count > 1.8 *10^9/L, hemoglobin > 8.0g/dl, platelet > 75 * 10^9/L
- hepatic and renal function in 2 weeks prior to study entry should be normal
- study entry within 60 days from whichever comes later: surgery or last chemotherapy
- women of childbearing potential must have a negative urine or serum pregnancy test with 2 weeks of study entry
- signs study specific informed consent prior to study entry
Exclusion Criteria:
- breast cancer with stage III/III (AJCC 7th)
- occult breast cancer
- in-situ breast carcinoma
- bilateral breast cancer
- male breast cancer
- breast lymphoma or breast sarcoma
- combined with Paget's disease
- received preoperative treatment(including neoadjuvant chemotherapy, endocrine therapy and target therapy
- positive surgical margin
- axillary lymph nodes dissection or sentinel lymph node biopsy omitted
- regional lymph nodes radiation needed
- boost volume larger than 1/4 of the whole breast
- tumor bed unable to recognize on CT
- prior invasive malignant tumor history
- prior radiation to thoracic
- connective tissue disease, such as active systemic lupus erythematosus and scleroderma, etc.
severe, active co-morbidity, defined as follows:
- unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- severe, acute bacterial or fungal infection within the last 2 weeks
- chronic obstructive pulmonary disease exacerbation or other respiratory illness within 30 days
- pregnant women
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：SIB group
Radiation therapy: daily 5 days per week for 3 weeks. 43.5 Gy in 15 fractions to the whole breast 49.5 Gy in 15 fractions to the tumor bed boost |
Radiation to the whole breast: 43.5 Gy in 15 fractions in 3 weeks. Simultaneous radiation to the surgical cavity: 49.5 Gy in 15 fractions in 3 weeks. Intensity modulated radiation treatment is used. |
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 |
|---|---|---|
|
acute radiation induced dermatitis by CTCAE within 3 months
時間枠：3 months
|
radiation induced skin toxicity, including rash, dry skin, ulceration etc., occurring immediately after radiation.
|
3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
late radiation toxicity by CTCAE every 3 months to 1 years after 3 months of completion of radiation
時間枠：3 months to 1 year
|
any radiation induced toxicity occurring after the radiation
|
3 months to 1 year
|
|
breast cosmetic result as measured by Harvard scale of breast cosmesis (excellent, good, fair, poor) every 3 months for 1year
時間枠：every 3 months for 1year
|
breast cosmetic evaluation after breast conserving surgery and radiation, using Harvard scale.
|
every 3 months for 1year
|
|
quality of life as measured by Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) every 3 months for 1 year
時間枠：every 3 months for 1 year
|
Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) is used to evaluated the quality of life: all scale range: 0-144; sub-scale range: physical well being: 0-28; social well being: 0-28; emotional well being 0-24; functional well being 0-28; additional consideration: 0-36; the higher the better
|
every 3 months for 1 year
|
|
quality of life as measured by Breast Cancer Treatment Outcome Scale(BCTOS) every 3 months for 1 year
時間枠：every 3 months for 1 year
|
Functional Assessment of Breast Cancer Treatment Outcome Scale(BCTOS) is used to evaluated the quality of life.
the range of BCTOS is 22-88, the smaller the better
|
every 3 months for 1 year
|
|
in-breast recurrence rate at 1 year of radiation completion
時間枠：1 year
|
recurrence occurred in the treated breast.
|
1 year
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Yexiong Li, Professor、Cancer Hospital/Institution, Chinese Academic Medical Sciences and Peking Union Medical College
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.
- Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.
- START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19.
- START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19.
- Hamilton DG, Bale R, Jones C, Fitzgerald E, Khor R, Knight K, Wasiak J. Impact of tumour bed boost integration on acute and late toxicity in patients with breast cancer: A systematic review. Breast. 2016 Jun;27:126-35. doi: 10.1016/j.breast.2016.03.002. Epub 2016 Apr 22.
- Chadha M, Vongtama D, Friedmann P, Parris C, Boolbol SK, Woode R, Harrison LB. Comparative acute toxicity from whole breast irradiation using 3-week accelerated schedule with concomitant boost and the 6.5-week conventional schedule with sequential boost for early-stage breast cancer. Clin Breast Cancer. 2012 Feb;12(1):57-62. doi: 10.1016/j.clbc.2011.09.002. Epub 2011 Nov 6.
- Cante D, Franco P, Sciacero P, Girelli G, Marra AM, Pasquino M, Russo G, Borca VC, Mondini G, Paino O, Barmasse R, Tofani S, Numico G, La Porta MR, Ricardi U. Five-year results of a prospective case series of accelerated hypofractionated whole breast radiation with concomitant boost to the surgical bed after conserving surgery for early breast cancer. Med Oncol. 2013 Jun;30(2):518. doi: 10.1007/s12032-013-0518-7. Epub 2013 Mar 5.
- Freedman GM, White JR, Arthur DW, Allen Li X, Vicini FA. Accelerated fractionation with a concurrent boost for early stage breast cancer. Radiother Oncol. 2013 Jan;106(1):15-20. doi: 10.1016/j.radonc.2012.12.001. Epub 2013 Jan 17.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年1月1日
一次修了 (実際)
2019年1月1日
研究の完了 (実際)
2019年1月1日
試験登録日
最初に提出
2017年7月25日
QC基準を満たした最初の提出物
2017年10月23日
最初の投稿 (実際)
2017年10月25日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月31日
QC基準を満たした最後の更新が送信されました
2019年1月30日
最終確認日
2019年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- NCC2016YQ-19
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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