ISRCTN62704822已完成未知
3D conformal Radiation therapy for Accelerated Partial breast IrraDiation (RAPID) trial
McMaster University (Canada)0 个研究点目标入组 2,128 人开始时间: 2008年6月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 2,128
研究概览
简要总结
2013 Interim results article in http://ascopubs.org/doi/full/10.1200/JCO.2013.50.5511 interim results (added 14/02/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31813635/ (added 08/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Modifications as of 18/11/2008: point three of the inclusion criteria has been updated as follows:
- •3. Negative axillary node involvement including micrometastasis less than or equal to 0.2 mm or positive cells only identified by immunohistochemistry (IHC) as determined by:
- •3.1. Sentinel node biopsy
- •3.2. Axillary node dissection
- •3.3. Clinical exam for patients with DCIS only
- •Initial information at time of registration:
- •1. Female patients, 40 years and older, with a new histological diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast with no evidence of metastatic disease
- •2. Treated by breast-conserving surgery (BCS) with microscopically clear resection margins (or no residual disease on re-excision) and considered a candidate for breast irradiation
- •3. Negative axillary node involvement determined by sentinel node biopsy, axillary node dissection or clinical exam in women greater than 70 years of age
排除标准
- •Modifications as of 18/11/2008: the exclusion criteria have been updated as follows:
- •1. Aged less than 40 years
- •2. A known deleterious mutation in BRCA 1 and/or BRCA 2
- •3. Tumour size greater than 3 cm in greatest diameter on pathological examination (including both invasive and non-invasive components)
- •4. Tumour histology limited to lobular carcinoma only
- •5. Bilateral invasive or non-invasive malignancy of the breast (synchronous or metachronous)
- •6. More than one primary tumour in different quadrants of the same breast
- •7. Previous irradiation to the ipsilateral breast that would preclude WBI
- •8. Presence of an ipsilateral breast implant or pacemaker
- •9. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment
- •10. Oestrogen receptor status (ER) not known
- •11. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 12 weeks of the last surgical procedure on the breast
- •12. For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of the last dose of chemotherapy
- •13. History of cancer:
- •13.1. Patients with another active malignancy or malignancy treated less than 5 years prior to randomisation are excluded with the exception of prior non-invasive contralateral breast cancer
- •13.2. Patients with a prior diagnosis of invasive breast cancer in either breast are excluded regardless of disease free interval
- •13.3. Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial
- •14. Currently pregnant or lactating
- •15. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol
- •16. Geographic inaccessibility for follow-up
- •17. Inability to localise surgical cavity on CT (i.e., no evidence of surgical clips or seroma)
- •18. Inability to adequately plan the patient for the experimental technique. The Dose Evaluation Volume (DEV) should be less than or equal to 25% of the total breast volume, or less than or equal to 35% whilst meeting other criteria mentioned in full in the protocol.
- •Initial information at time of registration:
- •1. Any patient with known breast cancer genes (BRCA 1 or 2)
- •2. Aged less than 40 years
- •3. Tumour greater than 3 cm in greatest diameter on pathological examination
- •4. Tumour histology involving lobular carcinoma
- •5. Inability to localise surgical cavity on computed tomography (CT) (i.e., no evidence of surgical clips or seroma)
- •6. Inability to adequately plan the patient for the experimental technique; seroma should be less than 25% of the total breast volume
- •7. Bilateral invasive malignancy of the breast (synchronous or metachronous)
- •8. More than one primary tumour in different quadrants of the same breast
- •9. Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, contralateral non-invasive breast cancer, and invasive carcinomas o
研究者
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