A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy - NRG ONCOLOGY NSABP B-51/RTOG 1304 A Randomized Phase 3 Clinical Trial Evaluating Regional Nodal XRT in Patients Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

RG Oncology0 个研究点目标入组 1,636 人开始时间: 2016年2月15日最近更新: 2023年10月17日

适应症

试验速览

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•1) Definitive clinical or radiologic evidence of metastatic disease. 2) T4 tumors including inflammatory breast cancer. 3) Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone. 4) N2 or N3 disease detected clinically or by imaging. 5 Histologically positive axillary nodes post neoadjuvant therapy. 6)Microscopic positive margins after definitive surgery. 7) Synchronous or previous contralateral invasive breast cancer or DCIS. 8) Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy 9) History of non-breast malignancies within 5 years prior to randomization. 10) Any radiation therapy for the currently diagnosed breast cancer prior to randomization. 11) Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy. 12) Prior breast or thoracic RT for any condition. 13) Active collagen vascular disease,specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. 14) Pregnancy or lactation at the time of study entry 15) Other non-malignant systemic disease that would preclude the patientfrom receiving study treatment or would prevent required follow-up. 16)Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the studyrequirements.

发起方

RG Oncology