Proton vs Photon IMRT Toxicity in Breast Cancer

Официальное название

Comparative Toxicity of Postoperative Proton Versus Photon Intensity-Modulated Radiotherapy(IMRT) in Breast Cancer: A Multicenter, Prospective, Observational Study

Обзор

This study aims to compare the differences in acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients, with a focus on evaluating their impact on critical organs, including the heart, lungs, skin, esophagus, thyroid, and lymphatic tissues. Eligible patients will be followed for at least one year to assess the incidence and severity of both acute and late toxicities, as well as differences in patient-reported outcomes (PROs), cosmetic outcomes following breast-conserving surgery, and overall quality of life.

Подробное описание

Eligible breast cancer patients will receive either 4005 cGy (RBE) in 15 fractions once daily or 4256 cGy (RBE) in 16 fractions once daily, five times per week. The radiation dose will be delivered to the ipsilateral chest wall or whole breast, with or without regional nodal irradiation, including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions. The decision to administer a tumor bed boost will be made by the treating physician. The boost may be delivered either sequentially (10-12.5 Gy (RBE) in 4-5 fractions) or concurrently (48-49.5 Gy (RBE) in 15-16 fractions). The treating physician will evaluate clinical indications to determine the necessity of regional nodal irradiation and whether the internal mammary nodes should be included in the regional nodal clinical target volume (CTV). All patients will undergo intensity-modulated radiation therapy (IMRT) or intensity-modulated proton therapy (IMPT).

The primary endpoint is a composite of toxicity events, including grade ≥2 ipsilateral arm lymphedema within one year post-radiotherapy, grade ≥2 lymphopenia within three months post-treatment, or grade ≥1 cardiac toxicity within one year post-treatment. Patients will be followed for at least one year to assess acute and late toxicities, cosmetic outcomes (patient-reported) in those undergoing breast-conserving surgery, and quality of life.

Due to the greater difficulty in enrolling patients for IMPT compared to IMRT, the study employs an unbalanced 2:1 allocation ratio (IMRT : IMPT = 2:1). Based on an alpha level of 0.05, 80% power, a 2:1 allocation ratio, an assumed 11% difference in toxicity rates between conventional radiotherapy and IMPT during and within one year post-treatment, and a 6.4% anticipated loss-to-follow-up rate, the estimated total sample size is 750 patients (500 in the IMRT/VMAT group and 250 in the IMPT group).

Вмешательства

• Лучевая терапия Intensity-modulated photon radiotherapy (IMRT/VMAT)
  Participants will receive photon intensity-modulated radiation therapy (IMRT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). The prescribed dose is either 4005 cGy in 15 fractions once daily, or 4256 cGy in 16 fractions once daily. For patients undergoing breast-conserving surgery with high-risk
• Лучевая терапия Intensity-modulated proton therapy (IMPT)
  Participants will receive photon Intensity-modulated proton therapy (IMPT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions). The prescribed dose is either 4005 cGy (RBE) in 15 fractions once daily, or 4256 cGy (RBE) in 16 fractions once daily. For patients undergoing breast-conserving surgery with

Первичные конечные точки

• Composite Toxicity Event [Срок оценки: 1 year]

Вторичные конечные точки (11)

• Acute Radiation-Induced Cardiac Toxicity (RTOG/EORTC) [Срок оценки: 3 months]
• Acute Radiation-Induced Non-Cardiac Toxicity (CTCAE v5.0) [Срок оценки: 3 months]
• Chronic Radiation-Induced Skin and Cardiac Toxicity (RTOG/EORTC) [Срок оценки: 1 year]
• Chronic Radiation-Induced Toxicity - Multi-System (CTCAE v5.0) [Срок оценки: 1 year]
• Late Radiation-Induced Breast Toxicity (LENT-SOMA) [Срок оценки: 1 year]
• Breast Cosmetic Outcome [Срок оценки: 1 year]
• Patient-Reported Outcomes (PROs) [Срок оценки: 3, 6, 12, 18, 24, 36,48, 60 months]
• Health-Related Quality of Life (HRQoL) [Срок оценки: 3, 6, 12, 24, 60 months]
• Dose-volume parameters of the Planning treatment volume (PTV) [Срок оценки: Upon completion of radiotherapy treatment planning, prior to the first fraction of treatment.]
• Dose-volume parameters of the organs at risk (OARs) [Срок оценки: From CT simulation through completion of all treatment fractions (approximately 4 weeks per patient)]
• Health-Related Quality of Life (HRQoL) [Срок оценки: 3, 6, 12, 24, 60 months]

Критерии участия

Критерии включения

• Female patients aged ≥18 years.
• Pathological diagnosis of invasive breast cancer or ductal carcinoma in situ.
• Undergone breast-conserving surgery or total mastectomy, with or without stage I breast reconstruction.
• For invasive carcinoma, sentinel lymph node biopsy, axillary lymph node sampling, or axillary lymph node dissection was performed.
• Required postoperative adjuvant radiotherapy.
• Karnofsky Performance Status (KPS) score ≥ 70.
• The estimated life expectancy of greater than 5 years .
• Planned to receive photon intensity-modulated radiotherapy (IMRT) or proton IMRT, with written informed consent obtained.

Критерии исключения

• Prior history of chest radiotherapy.
• Severe cardiopulmonary dysfunction or other conditions that contraindicate radiotherapy.
• Pregnancy or breastfeeding.
• Concurrent active malignancies.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07537712 · RJBC-PPTOX-BC · PPTOX-BC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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