Accelerated Partial Breast Irradiation With 3D-CRT and IMRT (APERT)
Accelerated Partial Breast Irradiation After Breast Conserving Surgery for Low-risk Invasive Breast Cancer: 3D Conformal Radiotherapy (3D-CRT) and Intensity Modulated Radiotherapy (IMRT) - Prospective Phase II Study
調査の概要
詳細な説明
It is a sequential phase II trial. Eligible patients after breast conserving surgery (BCS) are treated with accelerated partial breast irradiation (APBI) using three-dimensional conformal radiotherapy (3D-CRT) for the first 45 patients or intensity modulated radiotherapy (IMRT) for the second 45 patients.
Primary end-point of the study: late radiation side-effects at 5 years. Early stopping criteria: Not used as primary end-point is late side-effects. Interim analysis: Not planned Secondary end-points: cosmetic results, quality of life, local recurrence-free survival, regional recurrence free survival, distant metastasis free survival, relapse free survival, overall survival, cancer specific survival.
Null-hypothesis for primary end-point: The incidence of severe (>G2) late radiation side-effects after APBI using 3D-CRT or IMRT will not exceed 10%.
Stratification:
- by treatment delivery: 3D-CRT - first 45 patients; IMRT - second 45 patients
- by bra capsize: Capsize A-B; C; and D-D+
Treatment intervention: 9 x 4.1 Gy APBI using 3D-CRT (first 45 patients) or IMRT (second 45 patients) delivered within 5 days, using twice-a-day fractionation.
Clinical target volume (CTV) and Planning target volume (PTV) definition:
CTV = excision cavity + 20 mm minus the actual pathological surgical margin in mm PTV = CTV + 5 mm in each direction
Follow-up:
- ECOG PS, physical examination (inspection and palpation), registration of side-effects (RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer)) early and late radiation morbidity scoring scheme) and cosmetic results (using the Harvard scale) : 7-14 days after RT, than in every 3 months for 2 years, and every 6 months for 5 years.
- Mammography: at 6, 12, 18, 24 months, and annually thereafter
- Quality of life questionnaire (QLQ) (e.g. EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and Breast (BR)-23) before RT, at 7-14 days after RT, at 3, 6, and 12 months, and annually thereafter
- digital photography: before treatment, at 7-14 days after treatment, and yearly thereafter
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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-
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Budapest、ハンガリー、H-1122
- National Institute of Oncology
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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
説明
Inclusion Criteria:
- previous breast conserving surgery within 12 weeks (in case of adjuvant chemotherapy within 28 days after completion of chemotherapy)
- patient age > 40 years
- ECOG performance status: 0-1
- life expectancy >5 years
- invasive ductal, papillary, mucinous, medullary or tubular carcinoma
- unifocal tumor
- pathological tumor size < or = 30 mm
- pathological negative axillary nodal status with axillary dissection or sentinel lymph node biopsy
- surgical clips in the tumor bed
- pathological surgical free margins of at least 2 mm
- written informed consent of patients
Exclusion Criteria:
- Stage III-IV
- multifocal tumor
- extensive intraductal component (EIC)
- ductal or lobular carcinoma in situ (DCIS or LCIS)
- invasive lobular cancer (ILC)
- lymph-vascular invasion (LVI)
- contralateral breast cancer
- history of treatment for previous breast cancer
- lactation or breast feeding women
- Paget-disease of the nipple
- psychiatric disorder
- increased radiosensitivity (e.g. collagen vascular disease)
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
- 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：Accelerated partial breast irradiation
Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy
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9 x 4.1 Gy accelerated partial breast irradiation delivered by 3D-CRT or IMRT over 5 consecutive days, using twice-a-day fractionation.
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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 |
|---|---|---|
|
late radiation side-effect
時間枠：5 years
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Late radiation side-effects at 5 years scored by the RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer) late radiation morbidity scoring scheme
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5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
cosmetic results
時間枠：5 years
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cosmetic results at 5 years measured by the Harvard criteria
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5 years
|
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local tumor control
時間枠：5 years
|
Local tumor control defined as reappearance of the tumor in the ipsilateral breast
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5 years
|
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regional tumor control
時間枠：5 years
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regional tumor control at 5 years
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5 years
|
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overall survival
時間枠：5 years
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overall survival at 5 years
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5 years
|
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disease free survival
時間枠：5 years
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disease free survival at 5 years
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5 years
|
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cancer specific survival
時間枠：5 years
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cancer specific survival at 5 years
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5 years
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
quality of life
時間枠：5 years
|
quality of life measured by the EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and BR-23 questionnaires
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5 years
|
協力者と研究者
捜査官
- スタディチェア：Csaba Polgár, MD, PhD, MSc、National Institute of Oncology
- 主任研究者：Norbert Mészáros, MD、National Institute of Oncology
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。
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