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

2021年3月4日 更新者：Eduardo Barbieri、Instituto Brasileiro de Controle do Cancer

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

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (预期的)

36

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Eduardo Barbieri
  • 电话号码：+551198639-1945
  • 邮箱：edurxt@gmail.com

研究联系人备份

学习地点

  • 巴西
    • SP
      • Sao Paulo、SP、巴西、03102-002
        • 招聘中
        • IBCC Oncologia
        • 接触：
        • 首席研究员：
          • Eduardo Barbieri
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Active Comparator: Standard
Whole breast Radiotherapy, 40 Gray (40Gy) fractions
辐射：Active Comparator: Standard
Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
实验性的：Experimental 1: Hypofractionated radiotherapy
Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions
辐射：Experimental 1: Hypofractionated radiotherapy
Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
实验性的：Experimental 2: Accelerated Partial Breast Irradiation
Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.
辐射：Experimental 2: Accelerated Partial Breast Irradiation
Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rate of local recurrence
大体时间：5 years
To estimate and compare the rate of local recurrence between the experimental and control arms.
5 years

次要结果测量

结果测量
措施说明
大体时间
Time to occurrence of distant metastases
大体时间：5 years
Distant tumor time is defined as number of days from randomization until occurrence of distant metastases, death without prior distant progression, or end of follow-up.
5 years
Disease-free survival
大体时间：5 years
Disease-free survival, defined as number of days from randomization until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
5 years
Overall survival
大体时间：5 years
Overall survival time, defined as number of days from randomization until death or end of follow-up.
5 years
Medico-economic study
大体时间：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Health-related Quality of Life
大体时间：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patients quality of life with the help of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). This questionnaire was designed to be cancer specific, multidimensional in structure, suitable for self-administration (brief and easy to complete), and applicable in a wide range of cultural contexts. The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.
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)
大体时间：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life with the help of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
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)
大体时间：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life with the help of the Functional Assessment of Cancer Therapy-Fatigue (FACT-F). Scores are interpreted according to the guidelines of the Scoring Manual. The higher the number of points, the better the quality of life. To obtain the score, the negative questions are reverted; then the answers of the domains are added up, and a proportional average is carried out in case of non answered items.
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Measurement Satisfaction of Body Image of the participants
大体时间：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life and patient satisfaction with the help of the Body Image Scale (BIS). Scores are interpreted according to the guidelines of the Scoring Manual. The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Changes in anxiety and depression
大体时间：Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life and patient satisfaction with the help of the Hospital Anxiety and Depression Scale (HADS). Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Early and late adverse effects in normal tissues
大体时间：5 years
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
5 years
Late adverse effects
大体时间：5 years
To evaluate if the patient had symptoms of swelling or edema in the arm, breast shrinkage, hardness, pigmentation, necrosis, pain and tenderness in the breast.
5 years
Acute toxicity rate
大体时间：5 years
To evaluate acute toxicity rate. The maximum grade for acute toxicity will be recorded for each patient at each treatment evaluation using Common Terminology Criteria for Adverse Events.
5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Instituto Brasileiro de Controle do Cancer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月4日

初级完成 (预期的)

2025年12月7日

研究完成 (预期的)

2026年12月31日

研究注册日期

首次提交

2020年12月4日

首先提交符合 QC 标准的

2020年12月9日

首次发布 (实际的)

2020年12月17日

研究记录更新

最后更新发布 (实际的)

2021年3月8日

上次提交的符合 QC 标准的更新

2021年3月4日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 38341220.8.0000.0072

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The findings will be shared and discussed with all investigators in the study. A study manuscript, having received contributions from all authors, will be submitted for publication in scientific circles.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Active Comparator: Standard的临床试验

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赞助者和合作者

医疗条件

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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