Radiation Dose Intensity Study in Breast Cancer in Young Women
Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed
研究概览
详细说明
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.
The second, very important aim of this study is to investigate whether we can find genetic or protein profiles that correlate with LRR, lymph node metastases, distant metastases, survival, radiosensitivity, and age. For this purpose we will obtain frozen tumor material and blood samples of as many patients as possible.
Population, study design, intervention:
Patients younger than 51 years of age, with stage T1-2N01-2aM0 breast cancer, and where the tumor can be locally excised with acceptable cosmetic result, will be randomized between a 16 Gy boost dose to the tumorbed and a 26 Gy boost dose to the tumor bed, after 50 Gy WBRT. Patients will be stratified based on age, tumor size, lymph node metastases, estrogen receptor status, interstitial or external boost irradiation, and institution. In principle frozen tumor samples and blood samples will be stored of each patient.
Endpoints and statistics:
The primary endpoint is LRR are 10 years. The secondary endpoint is cosmetic result, which will be quantified using digitized color photographs. In addition, patients will be asked to give their opinion about the cosmetic result using standardized questionnaires.
To find an increase in the local control rate of 88% to 93% at 10 year, with a power of 80% and a significance level of 5%, 580 patients will be included in each treatment arm.
Side studies:
An extremely important aspect of this trial is to obtain fresh tumor material and blood samples. These will be used to determine genetic and protein profiles aimed at finding subgroups based on these profiles, which may take more or less advantage of the additional radiation treatment.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Besancon、法国、25030
- Hôpital J-Minjoz
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Bordeaux、法国、33076
- Institut Bergonie
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Creteil、法国、94000
- CHU Henri Mondor
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Lille、法国、59000
- Centre Oscar Lambret
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Marseille、法国、13009
- Institut Paoli Calmettes
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Montpellier cedex 5、法国、34298
- Centre Val D'Aurelle
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Nice、法国、06189
- Centre Antoine Lacassagne
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Paris、法国、75010
- Hopital Saint Louis
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Paris、法国、75005
- Institut Curie
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Pierre Benite Cedex、法国、69495
- Centre Hospitalier Lyon Sud
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Rennes、法国、35000
- Centre Eugène Marquis
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Rouen、法国、76000
- Centre Henri Becquerel
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Saint Cloud、法国、92210
- Centre René Huguenin
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Saint Herblain Cedex、法国、44805
- Centre Rene Gauducheau
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Strasbourg、法国、67085
- Centre Paul Strauss
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Tours、法国、37000
- CHU de Tours
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Villejuif、法国、94800
- Institut Gustave Roussy
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Amsterdam、荷兰、1066 CX
- The Netherlands Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- 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 M0.
- 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.
Exclusion criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:1
low dose boost (16 Gy)
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high dose boost
low dose versus high dose
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实验性的:2
high boost (26 Gy)
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high dose boost
low dose versus high dose
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Local control at 10 yr
大体时间:at every follow up visit (< 2 months after last radiation treatment and thereafter yearly
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at every follow up visit (< 2 months after last radiation treatment and thereafter yearly
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次要结果测量
结果测量 |
大体时间 |
---|---|
Cosmetic outcome
大体时间:prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years
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prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years
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合作者和调查者
合作者
调查人员
- 学习椅:Liesbeth Boersma, MD、MAASTRO Clinic, Heerlen
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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