Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
- 试验地点
- 18
- 主要终点
- Local control at 10 yr
研究概览
简要总结
hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.
详细描述
Title of the study:
Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed.
Background and aim of the study:
Several studies showed that breast conserving therapy (BCT) yields similar survival rates as mastectomy. BCT consists of lumpectomy followed by whole breast radiotherapy (WBRT). Three studies showed that an additional dose to the tumor bed, after 50 Gy WBRT, reduces the local recurrence rate (LRR). The largest of these 3 studies was a recent EORTC trial, which also showed that young age was an independent risk factor for LR after BCT.
In patients < 51 years of age, the LR rate was reduced with 50% after a 66 Gy dose to the tumor bed, compared to 50 Gy (5-year LRR 12% vs 5.9%, p < 0.02). However, the LRR in young women was still quite high (> 1% per year). Therefore the first aim of the study is to investigate whether an additional boost dose to the tumorbed (26 Gy) reduces the LRR further. Therefore, we will compare the effect of a low boost dose (16 Gy) with the effect of a high boost dose (26 Gy) on the LRR, but also on the cosmetic outcome.
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
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 50 years or younger.
- •Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma.
- •Tumor location and extension imaged prior to surgery using at least mammography and ultrasound.
- •Unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as:
- •any DCIS or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields).
- •Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed.
- •Breast cancer stage: pT1-2pN0-2a M
- •No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy).
- •In cases where no adjuvant chemotherapy is given, wide local excision has been performed < 10 weeks before the start of radiotherapy.
- •In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed < 6 months before the start of radiotherapy, and chemotherapy should be completed < 6 weeks before the start of radiotherapy.
- •In cases where hormonal treatment is planned, this is given after completion of the radiotherapy.
- •No previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- •ECOG performance scale 2 or less.
排除标准
- •Residual microcalcifications on mammogram.
- •All histological types of malignancies other than invasive adenocarcinoma.
- •In situ carcinoma of the breast, without invasive tumor.
- •Concurrent pregnancy.
- •Multicentric tumors, and multifocal. tumors excised using multiple excisions * Invasive breast cancer in both breasts.
研究组 & 干预措施
1
low dose boost (16 Gy)
干预措施: high dose boost (Radiation)
1
low dose boost (16 Gy)
干预措施: boost (Procedure)
2
high boost (26 Gy)
干预措施: high dose boost (Radiation)
2
high boost (26 Gy)
干预措施: boost (Procedure)
结局指标
主要结局
Local control at 10 yr
时间窗: at every follow up visit (< 2 months after last radiation treatment and thereafter yearly
次要结局
- Cosmetic outcome(prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years)