ISRCTN45066831已完成3 期
Radiation dose intensity study in breast cancer in young women: a randomised phase III trial of additional dose to the tumour bed
Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)0 个研究点目标入组 1,160 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,160
研究概览
简要总结
2015 results presented at 3rd ESTRO Forum 2015: https://www.researchgate.net/publication/281211644_OC-0389_The_influence_of_the_boost_dose_on_cosmetic_outcome_after_breast_conserving_therapy_results_of_the_Young_Boost_Trial [added 14/02/2019] 2018 results presented at Clinical Science Symposium: https://www.ejcancer.com/article/S0959-8049(18)30267-3/pdf [added 14/02/2019]
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 50 years or younger
- •2. Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma
- •3. Tumour location and extension imaged prior to surgery using at least mammography and ultrasound
- •4. Unicentric tumours and multifocal tumours removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as: any Ductal Carcinoma In Situ [DCIS] or invasive carcinoma in three 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)
- •5. Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed
- •6. Breast cancer stage: pT1-2pN0-2a M0
- •7. No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy)
- •8. In cases where no adjuvant chemotherapy is given, wide local excision has been performed less than 10 weeks before the start of radiotherapy
- •9. In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed less than 6 months before the start of radiotherapy, and chemotherapy should be completed less than 6 weeks before the start of radiotherapy
- •10. In cases where hormonal treatment is planned, this is given after completion of the radiotherapy
- •11. No previous history or synchronous malignant tumour 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
- •12. Eastern Cooperative Oncology Group (ECOG) performance scale 2 or less
排除标准
- •1. Residual microcalcifications on mammogram
- •2. All histological types of malignancies other than invasive adenocarcinoma
- •3. In situ carcinoma of the breast, without invasive tumour
- •4. Concurrent pregnancy
- •5. Multicentric tumours, and multifocal tumours excised using multiple excisions
- •6. Invasive breast cancer in both breasts
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