Randomised trial testing Intensity Modulated radiotherapy and Partial Organ RadioTherapy following breast conservation surgery for early breast cancer

Institute of Cancer Research (UK)0 个研究点目标入组 2,018 人开始时间: 2006年7月28日最近更新: 2020年1月21日

适应症

试验速览

•Current inclusion criteria as of 26/02/2019:
•1. Age greater than or equal to 50 years
•2. Primary breast conservation surgery +/- adjuvant systemic therapy
•3. Pathological tumour size ? 3.0 cm pT1-2 (< 3.1 cm, maximum microscopic diameter of invasive component)
•4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type)
•5. Unifocal disease
•6. Grade I, II or III
•7. Lymphovascular invasion present or absent
•8. Axillary lymph nodes negative or 1 to 3 nodes positive (pN0 or pN+(1-3))
•9. Minimum microscopic margin of non-cancerous tissue ? 2 mm (excluding deep margin if this is at deep fascia)
•10. No blood-borne metastases
•Previous inclusion criteria:
•1. Age greater than or equal to 50 years
•2. Primary breast conservation surgery +/- adjuvant systemic therapy
•3. Pathological tumour size less than or equal to 2.0 cm pT1a-c (maximum microscopic diameter of invasive component)
•4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type)
•5. Unifocal disease (Grade I or II)
•6. Minimum microscopic margin of non-cancerous tissue greater than or equal to 2 mm (excluding deep margin if this is at deep fascia)
•7. No lympho-vascular invasion
•8. Axillary lymph nodes negative, PN0 (sentinel node biopsy & isolated tumour cells less than 0.2 mm allowed)
•9. No blood borne metastases

•Current exclusion criteria as of 26/02/2019:
•1. Previous malignancy (other than non-melanomatous skin cancer)
•2. Mastectomy
•3. Invasive carcinoma of classical lobular type
•4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is <3.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible)
•5. Concurrent chemo-radiotherapy
•Previous exclusion criteria:
•1. Previous malignancy (other than non-melanomatous skin cancer)
•2. Mastectomy
•3. Invasive carcinoma of classical lobular type
•4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is less than 2.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible)
•5. Concurrent chemo-radiotherapy

发起方

Institute of Cancer Research (UK)