Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Rate of patients without any grade 2 and more toxicities within the planning target volume
研究概览
简要总结
- Prospective, open-label, bi-center study, assessing the clinical outcomes of adaptive breast radiotherapy with ETHOS in hypersensitive patients.
- Bi-centric with ETHOS center : ICM (Institut du Cancer de Montpellier) and ISC (Institut Sainte Catherine) Avignon
- 500 patients will be included:
- COHORTE A = Treatment ETHOS RT :46 evaluable patients with high risk of LRR and bf+ risk
- COHORT B = Conventional IMRT : 454 others patients with high risk of LRR and bf- risk
详细描述
- Breast cancer (BC) patients with high risk of severe radio-induced side effects
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as fibrosis, retraction or telangiectasia can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. A number of factors are known to increase the risk of radiation toxicity including individual radiosensitivity. While toxicity risks for populations of patients are known, the determination of an individual's normal tissue radiosensitivity is seldom possible before treatment.
Therefore, current practice standards commonly prescribe radiation dose according to clinical scenarios, without regard to the genotype or phenotype of the individual being irradiated.
In that context, several teams have developed and validated prospectively or retrospectively (a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA).
An excellent negative predictive value was found in the case of high RILA value and grade 0-1 late toxicity in breast cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years old.
- •Conservative breast cancer surgery or radical mastectomy.
- •At least pN1 breast cancers, regardless breast cancer subtypes.
- •Tumor negative margins.
- •Indication of whole breast and node irradiation.
- •Extension evaluation of disease will be proven negative (M0).
- •Risk level of breast fibrosis identified by the centralized NovaGray RILA Breast® test
- •Must be geographically accessible for follow-up.
- •Written and dated informed consent.
- •Affiliated to the French national social security system.
排除标准
- •Patients with distant metastases.
- •Bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast.
- •Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years.
- •Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
- •Patients treated with systemic investigational drugs within the past 30 days (Observational cohorts are accepted if the collection of data does not interfere with the current trial)
- •Untreated hypothyroidism
- •Patients known to be HIV positive (no specific tests are required to determine the eligibility).
- •Patients known as hypersensitive to radiation (ATM Homozygote, p53-/-,…)
- •Pregnant or breast-feeding women
- •Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study
- •Person deprived of their liberty or under protective custody or guardianship.
研究组 & 干预措施
Cohort A : Experimental group
In cohort A, for patients with high and undetermined risk of fibrosis (bf+), an adaptive BC RT (ETHOS) will be delivered.
干预措施: Treatment ETHOS radiotherapy (Radiation)
Cohort B : Control group
In cohort B, for patients with low risk of fibrosis (bf-), an IMRT will be delivered.
干预措施: Conventional IMRT (Radiation)
结局指标
主要结局
Rate of patients without any grade 2 and more toxicities within the planning target volume
时间窗: at 3 years
A toxicity of grade 2 and more is defined as an observation of grade 2 and more, in case of late toxicities it should be at least confirmed by two consecutive visits.
次要结局
- rate of Acute & late toxicity(From the start of RT to 12 weeks post RT and from 12 weeks post RT to 3 years post RT)
- Local recurrence rate (LRR)(at 3 years)
- Quality of life by using QLQ-C30 (and BR 23 module) questionnaire score(at 0/3/6/12/18/24/30/36 months post RT)
- Quality of life by using MFI questionnaire score(at 0/3/6/12/18/24/30/36 months post RT)
- Relapse-free survival (RFS) rate(at 3 years)
- Quality of life by using GPAQ questionnaire score(at 0/3/6/12/18/24/30/36 months post RT)
- Time to severe RT toxicities rate(at 3 years)
- Overall survival (OS) rate(at 3 years)