A Prospective Phase 3 Clinical Trial Of Postmastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Locoregional control rate ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse.
研究概览
简要总结
The purpose of this study is to compare the efficacy and toxicities of hypofractionated radiotherapy with conventional fractionated radiotherapy in high risk breast cancer patients treated with mastectomy. It's hypothesized that the efficacy and toxicities are similar between the two groups.
详细描述
Eligible breast cancer patients with mastectomy and axillary dissection are divided into two groups: conventional fractionated (CF) radiotherapy of 50 Gray (GY) in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region, and hypofractionated (HF) radiotherapy of 43.5 Gray (GY) in 15 fractions within 3 weeks to the same region. During and after radiotherapy , the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
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
- None
盲法说明
Check none
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer
- •Undergone total mastectomy and axillary dissection T 3-4 and/or 4 or more positive axillary lymph nodes.
- •Fit for chemotherapy ( if indicated) , endocrine therapy (if indicated), and postoperative irradiation.
- •Written informed concent.
- •C T3-4 , or C N2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy.
- •No supraclavicular or internal mammary nodes metastases.
- •No distant metastases .Enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who did't receive neoadjuvant therapy.
- •Enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and did't need adjuvant chemotherapy.
排除标准
- •Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
- •Previous or concurrent malignant other than non melanomatous skin cancer
- •Bilateral breast cancer.
- •Immediate or delayed ipsilateral breast cancer reconstruction.
研究组 & 干预措施
group (1)
Hypofractionated radiotherapy women with T3-4 and /or 4 or more axillary nodes involvement post mastectomy. Hypofractionated radiotherapy 43,5 GY/15 fractions (f) /3w. to chest wall and supraclavicular nodal region.
干预措施: Hypofractionated radiotherapy (Radiation)
group(2)
Conventional fractionated radiotherapy breast cancer women with T3-4 and/ or 4 or more axillary nodes involvement post mastectomy. Conventional fractionated radiotherapy 50 Gray(GY)/25 fractions (f)/5w to chest wall and supraclavicular nodal region.
干预措施: Conventional fractionated radiotherapy (Radiation)
结局指标
主要结局
Locoregional control rate ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse.
时间窗: two years
60 female patients with high risk post mastectomy breast cancer will divided randomly into two equal groups One group will received hypofractionated (HF) regimen of postoperative radiotherapy, and group two will receive conventional fractionated (CF) regimen of postoperative local radiotherapy. in high risk breast cancer , comparison between the two treated groups.
Frequency of local recurrence.
时间窗: one year
Comparison between the treatment groups.
Toxicity outcome/ side affects that may occur with breast radiation therapy.
时间窗: two years
Comparison between the two treatment groups regarding breast irradiation toxicity outcomes and its frequency.
Histopathologic grades of the tumor.
时间窗: one year
Comparison between the two treatment groups.
Pathological tumour size (pT stage classification)
时间窗: one year
cT 3-4
Pathological node status (pN stage classification) (cN)
时间窗: one year
cN 2 (4 or more positive axillary lymph nodes.
Frequency of distant metastasis
时间窗: two years
Compare two treatment groups regarding the frequency of distant metastasis.
次要结局
- Overall survival.(two years)
研究者
Ahmed Ahm
Dr.Hoda Hassan Mohammed Eisa, professor of clinical oncology and nuclear medicine
Assiut University