Radiation Therapy in Women With Low Risk Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery (IMPORT)
Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer.
PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating women with early-stage breast cancer who have undergone breast-conservation surgery.
調査の概要
詳細な説明
OBJECTIVES:
- To test partial breast radiotherapy using intensity-modulated techniques following complete local tumor excision in women with low-risk, early stage breast cancer.
OUTLINE: This is a multicenter study.
Patients are stratified according to center (not participating in sub-studies vs participating in sub-studies). Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo standard whole breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.
- Arm II: Patients undergo reduced whole breast radiotherapy (15 fractions) and standard partial breast radiotherapy (15 fractions) once daily on days 1-5 for 3 weeks.
- Arm III: Patients undergo standard partial breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.
All patients complete a family history questionnaire at baseline. Patients also undergo blood sample collection at baseline and paraffin-embedded tissue collection at follow-up for molecular studies analyzing inter-patient variation by microarrays.
Patients in centers participating in sub-studies undergo quality of life and health economic assessment at baseline, 6 months, and 1, 2, and 5 years. These patients also undergo photographic assessment at baseline, 2 years, and 5 years.
After completion of study treatment, patients are followed for 10 years.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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England
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Sutton、England、イギリス、SM2 5PT
- Royal Marsden - Surrey
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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
DISEASE CHARACTERISTICS:
Diagnosis of low-risk early stage breast cancer, meeting the following criteria:
Invasive adenocarcinoma
- No invasive carcinoma of classical lobular type
- lympho-vascular invasion present or absent
- Tumor size pathologically determined to be ≤ 3.0 cm in diameter (pT1-2) (< 3.1 cm maximum microscopic diameter of invasive component)
- Unifocal disease
- Grade I, II, or III disease
- Axillary lymph nodes negative or 1-3 nodes positive (pN0 or pN+(1-3))
Must have undergone breast conservation surgery with or without adjuvant systemic therapy
- Minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
- At low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence)
- No prior mastectomy
- No blood-borne metastases
PATIENT CHARACTERISTICS:
- No prior malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
No prior endocrine therapy or chemotherapy
- Neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met
- No primary endocrine therapy as a replacement for surgery
- No concurrent chemoradiotherapy
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：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：Arm I (control)
Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.
|
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
|
|
実験的：Arm II
Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
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Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
|
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実験的：Arm III
Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
|
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
|
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 |
時間枠 |
|---|---|
|
Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment
時間枠：5 years
|
5 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Location of tumor relapse
時間枠：5 years
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5 years
|
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Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment
時間枠：5 years
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5 years
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Regional and distant metastases
時間枠：5 years
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5 years
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Late adverse effects in normal tissue normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments
時間枠：5 years
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5 years
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Quality of life as assessed by EORTC QLQ C-30, EORTC QLQ-BR23, BIS, and HADS questionnaires in a subset of patients at baseline, 6 months, and 1, 2, and 5 years
時間枠：5 years
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5 years
|
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Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years
時間枠：10 years
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10 years
|
協力者と研究者
捜査官
- 主任研究者：Charlotte E Coles, PhD、University of Cambrige, England
出版物と役立つリンク
一般刊行物
- Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.
- Bhattacharya IS, Haviland JS, Kirby AM, Kirwan CC, Hopwood P, Yarnold JR, Bliss JM, Coles CE; IMPORT Trialists. Patient-Reported Outcomes Over 5 Years After Whole- or Partial-Breast Radiotherapy: Longitudinal Analysis of the IMPORT LOW (CRUK/06/003) Phase III Randomized Controlled Trial. J Clin Oncol. 2019 Feb 1;37(4):305-317. doi: 10.1200/JCO.18.00982. Epub 2018 Dec 11.
- Kirby AM, Bhattacharya IS, Wilcox M, Haviland JS. The IMPORT LOW Trial: Collaborative Research Accelerates Practice Change in Breast Radiotherapy. Clin Oncol (R Coll Radiol). 2019 Jan;31(1):5-8. doi: 10.1016/j.clon.2018.08.007. Epub 2018 Sep 17. No abstract available.
- Coles C, Yarnold J; IMPORT Trials Management Group. The IMPORT trials are launched (September 2006). Clin Oncol (R Coll Radiol). 2006 Oct;18(8):587-90. doi: 10.1016/j.clon.2006.07.010. No abstract available.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
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 (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
本研究に関する用語
その他の研究ID番号
- CDR0000629768
- NIHR 2253 (その他の識別子：NIHR)
- ICR-CTSU/2006/10001 (その他の識別子：ICR-CTSU)
- ISRCTN12852634 (レジストリ識別子：ISRCTN)
- CRUK/06/003 (その他の助成金/資金番号：Cancer Research UK)
- 06/Q1605/128 (その他の識別子：Main Research Ethics Committee)
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
米国FDA規制機器製品の研究
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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