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临床试验/CTRI/2024/06/068847
CTRI/2024/06/068847尚未招募2 期

eoadjuvant Radiotherapy in breast Cancer, A study on the optimal sequencing of radiation in breast cancer. - NeoORB

All India Institute of Medical Sciences, Jodhpur0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1)Eligibility for NACT:
  • Patients with inoperable breast cancer:
  • a)Bulky or matted cN2 axillary nodes
  • b)cN3 nodal disease
  • c)cT4 tumors(Inflammatory breast cancer if disease can be contained in radiotherapy portal)
  • In select patients with operable breast cancer:
  • a)HER2-positive disease and TNBC, if =cT2 or =cN1
  • b)Large primary tumor relative to breast size in a patient who desires breast conservation.
  • c)cN+ disease likely to become cN0 with preoperative systemic therapy.
  • d)cT1c, cN0, HER2-positive disease and TNBC.
  • 2)Pathological evidence of breast cancer
  • 3)Informed consent for NACT signed by the patient
  • 4)Absence of Distant mets
  • 5)Age =18 years at the time of randomisation
  • 6)Performance status = 2

排除标准

  • 1)Pregnancy or lactation
  • 2)Prior radiotherapy of the affected or contralateral breast
  • 3)Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans
  • 4)Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA II or AHA C, pacemaker, and/or implanted defibrillator
  • 5)Other medical conditions that prohibit the neoadjuvant chemotherapy (i.e. psychiatric diseases, non-compliance, etc.)
  • 6)Patients with pure ductal carcinomas in situ.
  • 7)Patients with non-epithelial malignant conditions of the breast viz. Sarcomas, lymphomas, phyllodes tumors
  • 8)Synchronous primary

研究者

发起方
All India Institute of Medical Sciences, Jodhpur

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