Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery (LAPIDARY)
2021年3月4日 更新者：Eduardo Barbieri、Instituto Brasileiro de Controle do Cancer
Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery
Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.
There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.
調査の概要
状態
募集
条件
詳細な説明
The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.
研究の種類
介入
入学 (予想される)
36
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。
研究連絡先
- 名前：Eduardo Barbieri
- 電話番号：+551198639-1945
- メール：edurxt@gmail.com
研究連絡先のバックアップ
- 名前：Alayne D Yamada, PhD
- 電話番号：+55113474-4242
- メール：alayne.pesquisa@ibcc-mooca.org.br
研究場所
-
-
SP
-
Sao Paulo、SP、ブラジル、03102-002
- 募集
- IBCC Oncologia
-
コンタクト：
- Eduardo Barbieri
- 電話番号：+55 11 98639-1945
- メール：edurxt@gmail.com
-
主任研究者：
- Eduardo Barbieri
-
コンタクト：
- Alayne D Yamada, PhD
- 電話番号：+55113474-4242
- メール：alayne.pesquisa@ibcc-mooca.org.br
-
-
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
50年～90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:
- Information to the patient and signed informed consent;
- Women aged ≥50 years
- Breast conserving surgery
- Pathologic tumor size < 3 cm (maximum microscopic diameter of the invasive component)
- Invasive adenocarcinoma (except classic invasive lobular carcinoma)
- Unifocal disease
- Histopathologic grades I or II
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Lymphovascular invasion absent
- Negative axillary lymph nodes
- Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)
- No prior breast or mediastinal radiotherapy
- No hematogenous metastases
Exclusion Criteria:
- Previous malignancy (except non-melanomatous skin cancer)
- Mastectomy
- Classical-Type Invasive Lobular Carcinoma
- Neoadjuvant chemotherapy
- Human Epidermal growth factor Receptor-type 2 positive (HER2+)
- Triple-negative breast cancers
- Intravascular lymphoma present
- Contraindications to radiotherapy.
- No geographical, social or psychologic reasons that would prevent study follow
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
アクティブコンパレータ：Active Comparator: Standard
Whole breast Radiotherapy, 40 Gray (40Gy) fractions
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Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
|
|
実験的：Experimental 1: Hypofractionated radiotherapy
Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions
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Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
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実験的：Experimental 2: Accelerated Partial Breast Irradiation
Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.
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Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.
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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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Rate of local recurrence
時間枠：5 years
|
To estimate and compare the rate of local recurrence between the experimental and control arms.
|
5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to occurrence of distant metastases
時間枠：5 years
|
Distant tumor time is defined as number of days from randomization until occurrence of distant metastases, death without prior distant progression, or end of follow-up.
|
5 years
|
|
Disease-free survival
時間枠：5 years
|
Disease-free survival, defined as number of days from randomization until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
|
5 years
|
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Overall survival
時間枠：5 years
|
Overall survival time, defined as number of days from randomization until death or end of follow-up.
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5 years
|
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Medico-economic study
時間枠：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
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Health-related Quality of Life
時間枠：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patients quality of life with the help of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
This questionnaire was designed to be cancer specific, multidimensional in structure, suitable for self-administration (brief and easy to complete), and applicable in a wide range of cultural contexts.
The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
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Evaluation of quality of life change by European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
時間枠：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patient quality of life with the help of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23).
The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms.
The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
|
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
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Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F)
時間枠：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patient quality of life with the help of the Functional Assessment of Cancer Therapy-Fatigue (FACT-F).
Scores are interpreted according to the guidelines of the Scoring Manual.
The higher the number of points, the better the quality of life.
To obtain the score, the negative questions are reverted; then the answers of the domains are added up, and a proportional average is carried out in case of non answered items.
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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Measurement Satisfaction of Body Image of the participants
時間枠：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patient quality of life and patient satisfaction with the help of the Body Image Scale (BIS).
Scores are interpreted according to the guidelines of the Scoring Manual.
The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment.
The total score ranges from 0 to 30.
A higher score means a higher level of body image disturbance.
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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Changes in anxiety and depression
時間枠：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patient quality of life and patient satisfaction with the help of the Hospital Anxiety and Depression Scale (HADS).
Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21.
Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
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Early and late adverse effects in normal tissues
時間枠：5 years
|
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
|
5 years
|
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Late adverse effects
時間枠：5 years
|
To evaluate if the patient had symptoms of swelling or edema in the arm, breast shrinkage, hardness, pigmentation, necrosis, pain and tenderness in the breast.
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5 years
|
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Acute toxicity rate
時間枠：5 years
|
To evaluate acute toxicity rate.
The maximum grade for acute toxicity will be recorded for each patient at each treatment evaluation using Common Terminology Criteria for Adverse Events.
|
5 years
|
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。
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
- Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17.
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- Correa C, Harris EE, Leonardi MC, Smith BD, Taghian AG, Thompson AM, White J, Harris JR. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017 Mar-Apr;7(2):73-79. doi: 10.1016/j.prro.2016.09.007. Epub 2016 Sep 17.
- Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19.
- Polgar C, Fodor J, Major T, Sulyok Z, Kasler M. Breast-conserving therapy with partial or whole breast irradiation: ten-year results of the Budapest randomized trial. Radiother Oncol. 2013 Aug;108(2):197-202. doi: 10.1016/j.radonc.2013.05.008. Epub 2013 Jun 3.
- 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.
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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)
2021年3月4日
一次修了 (予想される)
2025年12月7日
研究の完了 (予想される)
2026年12月31日
試験登録日
最初に提出
2020年12月4日
QC基準を満たした最初の提出物
2020年12月9日
最初の投稿 (実際)
2020年12月17日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月8日
QC基準を満たした最後の更新が送信されました
2021年3月4日
最終確認日
2020年11月1日
詳しくは
本研究に関する用語
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?
いいえ
IPD プランの説明
The findings will be shared and discussed with all investigators in the study.
A study manuscript, having received contributions from all authors, will be submitted for publication in scientific circles.
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
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。