A prospective study to determine the disease response to Radiotherapy (34Gy/10 fractions) in patients of Inoperable Carcinoma breast not responding to Neo-Adjuvant Chemotherapy and factors influencing it.

Avni Saini1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2026年1月9日最近更新: 2025年12月29日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方
入组人数: 30
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This study seeks to establish the role of hypo-fractionated radiotherapy as a feasible and effective treatment modality for a difficult subset of inoperable and Neo-Adjuvant Chemotherapy non-responsive breast cancer patients, ultimately contributing to be enhanced clinical decision-making in such settings. This trial is an attempt to find the efficacy and tolerability in patients who has remained inoperable even after the Neo-Adjuvant Chemotherapy is completed. in a resource constrained high volume tertiary care centre like ours.

研究设计

研究类型: Interventional
分配方式: Na

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•Histologically confirmed locally advanced or recurrent breast carcinoma deemed inoperable.
•Patients unsuitable for surgery due to comorbidities, or patient refusal,
•Age: more than 18years.
•ECOG performance status 0-
•Stage of the disease T3/4, N positive, M positive or negative.
•Patients not responding to neoadjuvant chemotherapy
•Normal baseline complete blood counts, liver function tests, renal function tests, blood sugar.
•Patients who have received cardiological clearance with normal ECG and 2D Echocardiography scans
•Signed informed consent by the patient to participate in the study including willingness to join the novel treatment approach.

排除标准

•Prior radiation therapy to the same breast or chest wall
•Pregnant or lactating women.
•Evidence of uncontrolled co-morbidities e.g. uncompensated respiratory, cardiac, hepatic and renal issues.
•Refusal to undergo radiation therapy
•Patients with visceral crisis.
•Participation in any other interventional study on breast carcinoma.

研究者

发起方

Avni Saini

申办方类型

Other [self]

责任方

Principal Investigator

主要研究者

Avni Saini

Institute of Post Graduate Education and Research Kolkata

研究点 (1)

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