Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Fatigue 12 weeks
研究概览
简要总结
Breast cancer is the most frequent malignancy in women. Standard therapy for early-stage breast cancer is breast conserving surgery (BCS) followed by adjuvant whole breast irradiation (WBI), which usually requires a treatment time of 3-6 weeks. Several randomized controlled trials (RCTs) demonstrated that postoperative WBI after BCS significantly decreased the risk of local (in-breast) recurrence and improved breast cancer mortality as well as survival. However, one of the most common side-effects of radiotherapy is fatigue, which is reported in up to 80% of cancer patients during treatment. Especially in early-stage breast cancer patients it might be the only serious side-effect following adjuvant irradiation, as fatigue often significantly reduces quality of life due to resulting functional impairment and psychological distress. Fatigue additionally has a distinct socioeconomic impact: 75% of patients and 40% of caregivers are forced to change their employment status due to cancer-related fatigue.
For reducing treatment-related toxicity, several RCTs consequently addressed the question whether adjuvant WBI could be omitted in early-stage, low risk breast cancer patients treated with endocrine therapy. However, all these trials detected up to seven-time increased local recurrence rates without WBI following BCS. Both, longer duration of radiotherapy and larger radiation field sizes are known to be associated with increase in treatment-related fatigue. Accelerated partial breast irradiation (APBI), delivered exclusively to the original tumor location and not to the surrounding breast tissue, might therefore be an alternative treatment option with fewer side-effects for early-stage, low risk breast cancer patients. Few previous trials have already reported comparable outcomes for highly selected low-risk breast cancer patients for APBI compared to conventional WBI. First results also point out that APBI compared to WBI might be associated with less severity and intensity of fatigue.
One method for APBI is single-dose intraoperative radiotherapy (IORT) delivered directly to the tumor after resection. Data is still limited for APBI, hence current international and German guidelines suggest the use of APBI for low-risk early stage breast cancer patients but recommend the application of APBI preferably within a clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive breast cancer
- •Total tumor size < 2.5 cm
- •estrogen receptor positive, HER2-receptor negative on immunohistochemistry
- •age >= 50 years
- •ECOG (Eastern Cooperative Oncology Group) Performance status ≤ 2
- •Ability of subject to understand character and individual consequences of the clinical trial
- •Written informed consent (must be available before enrolment in the trial)
排除标准
- •Extensive microcalcifications
- •Invasive lobular carcinoma
- •Clinically involved lymph nodes
- •No invasive axillary lymph node staging planned
- •Patients with significant mental or physical comorbidities that preclude regular follow-up
- •Neoadjuvant chemotherapy or neoadjuvant endocrine therapy
- •previous radiotherapy of the breast
- •Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- •Pregnant or lactating women
- •Participation in another competing clinical study or observation period of competing trials
研究组 & 干预措施
BCS + WBI
breast conserving surgery followed by whole breast irradiation
干预措施: whole breast irradiation (Radiation)
BCS + IORT
Breast conserving surgery incl intraoperative radiotherapy
干预措施: intraoperative radiotherapy (Radiation)
结局指标
主要结局
Fatigue 12 weeks
时间窗: 12 weeks
Assessment of fatigue from baseline (before treatment start) compared to 12 weeks after treatment start as assessed by the FACIT (Functional Assessment of Cancer Therapy) Fatigue Assessment Questionnaire. Scale ranges from 0 (no fatigue) to 52 (maximum fatigue).
次要结局
- Fatigue 5 weeks, 6 months, 2 years, 5 years after treatment start(5 weeks, 6 months, 2 years, 5 years after treatment start)
- distant tumor control(2 years and 5 years after treatment start)
- Local tumor control in the index quadrant of the breast(2 years and 5 years after treatment start)
- Local tumor control in the ipsilateral breast(2 years and 5 years after treatment start)
- Quality of life employing BREAST-Q questionnaire(5 weeks, 12 weeks, 6 months, 2 years, 5 years after treatment start)
- Quality of life employing EORTC (European Organisation for Research and Treatment of Cancer) Quality of life questionnaires (QLQ)-C30(5 weeks, 12 weeks, 6 months, 2 years, 5 years after treatment start)
- Quality of life employing BCTOS (Breast Cancer Treatment Outcome Scale) questionnaire(5 weeks, 12 weeks, 6 months, 2 years, 5 years after treatment start)
- Overall survival(2 years and 5 years after treatment start)
- Disease-free survival(2 years and 5 years after treatment start)
- Acute toxicity(5 weeks after treatment start)
- Chronic toxicity(6 months, 2 years and 5 years after treatment start)
- Secondary malignancies(2 years and 5 years after treatment start)
- Cosmesis(5 weeks, 12 weeks, 2 years, 5 years after treatment start)
- Regional tumor control(2 years and 5 years after treatment start)
研究者
Juergen Debus
Principal Investigator
University Hospital Heidelberg