NCT06677879招募中2 期
A Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.
Shanghai Proton and Heavy Ion Center1 个研究点 分布在 1 个国家目标入组 780 人开始时间: 2024年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years
研究概览
简要总结
The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are:
- What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery?
- What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive breast cancer.
- •Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:
- •Post lumpectomy: Patients who have undergone lumpectomy with postoperative pathology staged as pT1-3 N1-3, excluding N3c.
- •Post mastectomy: Patients who have undergone mastectomy, with postoperative pathology staged as pT1-3 N1-3, excluding N3c, and who have had an implant (prosthesis or tissue expander) placed.
- •Neoadjuvant therapy patients: Patients who have received neoadjuvant chemotherapy or endocrine/targeted therapy and have a postoperative stage of ypT1-3 N0-3, excluding N3c, requiring radiotherapy to the chest wall/breast and regional lymphatic drainage areas.
- •No distant metastasis.
- •Age range: 18-80 years.
- •Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0-
- •Non-pregnant and non-lactating women.
- •Informed consent: Patients must provide written informed consent prior to receiving radiotherapy.
排除标准
- •Presence of Ductal Carcinoma In Situ (DCIS).
- •Tumor staging: Patients presenting with T4, N0, or N3c disease.
- •History of prior radiotherapy to the ipsilateral chest or breast.
- •Surgical margin status: Margins are either positive or close, defined as:
- •Invasive carcinoma within 1 mm of the surgical margin.
- •Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.
结局指标
主要结局
The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years
时间窗: Until 2 years after radiotherapy
We will record the incidence of ≥ 2 degree radiation-associated toxicity, such as breast or chest wall oedema, dermatitis, breast pain, esophagitis, rib fracture, radiation pneumonia and hypothyroidism and so on. The incidence of all the above is the primary outcome.
次要结局
- Late toxicities after 2 years of radiotherapy(Until 5 years after radiotherapy)
- Locoregional recurrence (LRR)(Until 5 years after treatment.)
- Disease-free survival (DFS)(Until 5 years after treatment.)
- Overall survival (OS)(Until 5 years after treatment.)
- uality of life, as measured by EORTC Quality of Life Questionnaires-B23(During last week of radiotherapy, at 3 months post radiotherapy and 1,3 and 5 years post radiotherapy)
- Cosmetic outcome(Until 5 years after treatment.)
研究者
Qing Zhang,MD
professor
Shanghai Proton and Heavy Ion Center
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Combination of Proton Therapy With Immunotherapy in Multiple Metastases CancerProton TherapyImmunotherapyNeoplasm MetastasisNCT03765190Peking University First Hospital30
进行中（未招募）
1 期
A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung CancerLung NeoplasmsNCT01770418Proton Collaborative Group32
招募中
3 期
PPI Versus Histamine Antagnists as Adjuvant to ChemotherapyLymphomaNCT03647072Sherief Abd-Elsalam60
Unknown
不适用
Data Collection of Normal Tissue Toxicity for Proton Therapy for PediatricsPediatric CancerNCT01502150M.D. Anderson Cancer Center798
已完成
不适用
Proton Therapy for Unresectable Cancer (CA) of PancreasPancreatic CancerNCT00685763University of Florida13