Randomised trial testing dose escalated intensity modulated radiotherapy in women with higher than average local tumour recurrence risk after breast conservation therapy for early breast cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,621
研究概览
简要总结
2006 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/17051947 protocol 2007 Other publications in https://doi.org/10.1016/j.clon.2007.01.320 forward planning analysis 2011 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/20605349 Trial planning 2014 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/25642565 Results of observational sub-study comparing image-guided radiotherapy and standard imaging. 2015 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/26492402 clinical impact results 2019 Abstract results in https://doi.org/10.1158/1538-7445.SABCS18-GS4-05 3-year adverse event results presented at San Antonio Breast Cancer Symposium (added 30/12/2022) 2021 Abstract results in https://www.estro.org/Congresses/ESTRO-2021/499/profferedpapers16-late-breakingabstracts/3418/importhightrial-doseescalatedsimultaneousintegrate Presented at ESTRO (added 30/12/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37302395/ (added 12/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 26/02/2019:
- •1. Operable unilateral breast cancer (T1-3, pN0- pN3a, M0 at presentation)
- •2. Breast conserving surgery
- •3. Age greater than or equal to 18 years
- •4. Histological confirmation of invasive carcinoma
- •5. Complete microscopic resection
- •6. Patient requires a tumour bed boost plus whole breast radiotherapy for inclusion within the trial
- •7. Written informed consent and available for follow-up
- •Previous inclusion criteria:
- •1. Age greater than or equal to 18 years
- •2. Operable, unilateral breast cancer (T1-3, N0-1, M0 at presentation)
- •3. Breast conserving surgery
- •4. Histological confirmation of invasive carcinoma
- •5. Complete microscopic resection
- •6. Patient requires a tumour bed boost plus whole breast radiotherapy
- •7. Written informed consent and availability for follow-up
排除标准
- •Current exclusion criteria as of 26/02/2019:
- •1. Past history of malignancy except:
- •1.1. Basal cell skin cancer and CIN cervix uteri or
- •1.2. Non breast malignancy allowed if treated with curative intent and at least 5 years disease free
- •2. Mastectomy
- •3. Concomitant chemotherapy (primary or sequential chemotherapy allowed).
- •4. Presence of ipsilateral breast implant
- •Previous exclusion criteria:
- •1. Previous malignancy (other than non-melanomatous skin cancer and Carcinoma In Situ [CIS] of the cervix)
- •2. Mastectomy
- •3. Concomitant chemotherapy (sequential chemotherapy allowed)
- •4. Radiotherapy prescription includes posterior axillary boost field