Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Лучевая терапия Active Comparator: Standard
  Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
• Лучевая терапия Experimental 1: Hypofractionated radiotherapy
  Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
• Лучевая терапия Experimental 2: Accelerated Partial Breast Irradiation
  Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.

Первичные конечные точки

• Rate of local recurrence [Срок оценки: 5 years]

Вторичные конечные точки (12)

• Time to occurrence of distant metastases [Срок оценки: 5 years]
• Disease-free survival [Срок оценки: 5 years]
• Overall survival [Срок оценки: 5 years]
• Medico-economic study [Срок оценки: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end]
• Health-related Quality of Life [Срок оценки: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end]
• 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) [Срок оценки: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end]
• Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F) [Срок оценки: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end]
• Measurement Satisfaction of Body Image of the participants [Срок оценки: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end]
• Changes in anxiety and depression [Срок оценки: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end]
• Early and late adverse effects in normal tissues [Срок оценки: 5 years]
• Late adverse effects [Срок оценки: 5 years]
• Acute toxicity rate [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• IBCC Oncologia — São Paulo

Публикации

• 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. PMID 22019144
• 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 Radiotherap PMID 26494415
• 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. PMID 23742961
• Veronesi U, Orecchia R, Maisonneuve P, Viale G, Rotmensz N, Sangalli C, Luini A, Veronesi P, Galimberti V, Zurrida S, Leonardi MC, Lazzari R, Cattani F, Gentilini O, Intra M, Caldarella P, Ballardini B. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial. Lancet Oncol. 2013 Dec;14(13):1269-77. doi: 10.1016/S1470-2045(1 PMID 24225155
• Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32 PMID 23835717
• 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. PMID 27866865
• 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. PMID 25605582
• Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. PMID 24055415

Идентификаторы

NCT: NCT04669873 · 38341220.8.0000.0072

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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