Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy Without Boost: Results of a Homogeneous Single Institution Experience
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- quality of life after hypofractionated adjuvant radiotherapy
研究概览
简要总结
This is a homogeneous, single institution, observational, non-interventional, prospective study of 500 patients who will be treated according to the standard protocol of adjuvant hypofractionated radiotherapy after breast conserving surgery, at a total dose of 40 Gy/ 15 fr (5 fr/ week, 3 consecutive weeks). In addition to the regular follow up, the patients will respond to the quality-of-life questionnaires (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC), general, QLQ- C30, and specific for breast (BR), QLQ- BR23, at the first visit, at the end of radiotherapy and at the subsequent follow-up visits from 6 months up to 5 and a half years, to evaluate the quality of life during and after the treatment.
The study also has a retrospective arm of approximately 3300 patients (number of patients and characteristics of disease expanded with the amendment presented to the Lombardia 1 Ethics Committee in May 22/2024), treated from January 2009, for whom disease control and toxicity will be evaluated.
详细描述
The study is observational, homogeneous (performed in a single institution), non-interventional, and composed of two parts: one retrospective and one prospective (for which we request the registration in the register of clinical trials).
The patients with breast cancer treated with adjuvant hypofractionated radiotherapy at the Department of Radiotherapy of "San Raffaele Scientific Institute" (IRCCSSRaffaele) from January 2009 will be identified and their clinical and dosimetric data retrieved and analyzed.
The objectives of the retrospective arm of the study are the analysis, with a follow up of 5 years, of acute and late toxicity, and clinical outcomes, such as local and regional control, overall survival, disease free survival and cancer-specific survival. A secondary objective is the identification of prognostic factors for toxicity and disease progression.
With the amendment approved by the Ethics Committee 1 of Lombardy Region in 22/05/2024 (CET Em. 195-2024) the number of patients in the retrospective arm was expanded to 3300. Were included: patients treated with moderate hypofractionated or ultra-hypofractionated radiotherapy to whole breast+/- simultaneous integrated boost to surgical bed, patients treated with accelerated partial breast irradiation, patients treated with hypofractionated radiotherapy to regional nodal irradiation and whole breast+/-SIB to surgical bed. The follow-up period was expanded to 10 years.
The objective of the prospective arm of the study, for a cohort of 500 consecutive patients who agree to participate in the study, is to assess the quality of life of the patients treated with hypofractionated short course (3 weeks) radiotherapy. The quality-of-life questionnaires (QLQ) of the European organization for research and treatment of cancer (EORTC): QLQ-C30 (general) and QLQ-BR23 (specific for the breast), will be distributed before radiation treatment, at the time of patient enrollment, at the end of therapy and during the follow up visits, for a duration of 5 years after the first follow up, scheduled first at 6 months and then annually.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients with TNM Classification of Malignant Tumours pathological stage Tis-T4d, N0-N3, treated with surgery (conservative or mastectomy), accelerated partial breast irradiation or whole breast hypofractionated radiotherapy +/-SIB +/- regional lymph node irradiation
排除标准
- •male breast cancer patients
结局指标
主要结局
quality of life after hypofractionated adjuvant radiotherapy
时间窗: up to 66 months
degree of general quality of life worsening of patients treated with hypofractionated adjuvant radiotherapy after breast conserving surgery assessed with EORTC quality of life questionnaires QLQ C30
breast specific quality of life after hypofractionated adjuvant radiotherapy
时间窗: up to 66 months
degree of specific quality of life worsening of patients treated with hypofractionated adjuvant radiotherapy after breast conserving surgery assessed with EORTC quality of life questionnaire QLQ BR23
次要结局
- Disease Free Survival(From the date of radiotherapy end until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 120 months)
- Regional Relapse Free Survival(From the date of radiotherapy end until the date of regional progression or date of death from any cause, whichever came first, assessed up to 120 months)
- Cancer Specific Survival(From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months)
- Overall survival(From the date of radiotherapy end until the date death from any cause, assessed up to 120 months)
- Acute toxicity(Up to three months from the start of radiotherapy)
- Late toxicity(From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months)
- Late skin toxicity(From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months)
- Local Relapse Free Survival(From the date of radiotherapy end until the date of local progression or date of death from any cause, whichever came first, assessed up to 120 months)
- Distant Metastases Free Survival(From the date of radiotherapy end until the date of distant progression or date of death from any cause, whichever came first, assessed up to 120 months)