Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
2026年6月21日 更新者：Rachel Beth Jimenez、Massachusetts General Hospital
Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation.
The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment).
Proton radiation delivers no dose beyond the region requiring treatment.
This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy.
In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.
調査の概要
詳細な説明
Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.
Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.
研究の種類
介入
入学 (実際)
70
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
-
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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-
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年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
- Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
- Life expectancy > 12 months
Exclusion Criteria:
- Pregnant or breast-feeding
- Prior therapeutic radiation > 200 cGy
- History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
- Prior investigation chemotherapy
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 |
|---|---|
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実験的：Proton Radiation
Radiation therapy with proton beam
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45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
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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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Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
時間枠：From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
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To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.
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From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
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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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The Number of Participants With Acute Skin Toxicities
時間枠：From the start of treatment until 3 months after the end of treatment
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Summary of the number of participants with any grade acute skin toxicities.
Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment.
Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From the start of treatment until 3 months after the end of treatment
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Rate and Severity of Radiation Pneumonitis
時間枠：From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
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The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
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Summary of Late Skin Toxicity
時間枠：From 3 months after the end of treatment up to 5 years
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A summary of the late skin toxicities experienced by participants.
The number of participants effected is shown for each toxicity experienced.
Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From 3 months after the end of treatment up to 5 years
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Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation
時間枠：From the start of treatment until 5 years post treatment
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Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment.
Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
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From the start of treatment until 5 years post treatment
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The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy
時間枠：Baseline and then 4 and 8 weeks post treatment
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The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram.
The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician.
Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion.
Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed.
Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.
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Baseline and then 4 and 8 weeks post treatment
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Progression Free Survival
時間枠：from the start of treatment until the time of disease progression, up to 5 years
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Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier.
Disease progression is defined as the appearance of one or more new lesions.
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from the start of treatment until the time of disease progression, up to 5 years
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To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome
時間枠：From the start of treatment until 5 years post treatment
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To evaluate cosmetic outcome and patient satisfaction with cosmetic outcome, see Secondary Outcome #7 for cosmetic outcomes.
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From the start of treatment until 5 years post treatment
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The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction
時間枠：From the start of treatment until 5 years post treatment
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The number of participants that needed unplanned additional surgery for breast reconstruction post-RT.
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From the start of treatment until 5 years post treatment
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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：Rachel B Jimenez, M.D.、Massachusetts General Hospital
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
- Jimenez RB, Hickey S, DePauw N, Yeap BY, Batin E, Gadd MA, Specht M, Isakoff SJ, Smith BL, Liao EC, Colwell AS, Ho A, Januzzi JL, Passeri J, Neilan TG, Taghian AG, Lu HM, MacDonald SM. Phase II Study of Proton Beam Radiation Therapy for Patients With Breast Cancer Requiring Regional Nodal Irradiation. J Clin Oncol. 2019 Oct 20;37(30):2778-2785. doi: 10.1200/JCO.18.02366. Epub 2019 Aug 26.
- Hassan MZO, Awadalla M, Tan TC, Scherrer-Crosbie M, Bakar RB, Drobni ZD, Zarif A, Gilman HK, Supraja S, Nikolaidou S, Zhang L, Zlotoff DA, Hickey SB, Patel SA, Januzzi JL, Keane F, Passeri JJ, Neilan TG, MacDonald SM, Jimenez RB. Serial Measurement of Global Longitudinal Strain Among Women With Breast Cancer Treated With Proton Radiation Therapy: A Prospective Trial for 70 Patients. Int J Radiat Oncol Biol Phys. 2023 Feb 1;115(2):398-406. doi: 10.1016/j.ijrobp.2022.08.036. Epub 2022 Aug 24.
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)
2011年6月1日
一次修了 (実際)
2017年4月1日
研究の完了 (実際)
2022年1月3日
試験登録日
最初に提出
2011年4月20日
QC基準を満たした最初の提出物
2011年4月20日
最初の投稿 (推定)
2011年4月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月20日
QC基準を満たした最後の更新が送信されました
2026年6月21日
最終確認日
2026年6月1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。