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临床试验/CTRI/2024/01/061017
CTRI/2024/01/061017尚未招募2 期

Feasibility of CT based contouring in Image Guided Adaptive Brachytherapy for Carcinoma Cervix using Information from MRI

Dr Ramkumar R1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年1月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
55
试验地点
1
主要终点
Local control at 3 months after completion of therapy

研究概览

简要总结

Project title is Feasibility of CT based contouring in Image Guided Adaptive Brachytherapy for Carcinoma Cervix using Information from MRI.

 Cervical cancer is the second most common cancer among women in India. Combined chemotherapy and brachytherapy is the treatment of choice in locally advanced cervical cancer.  In brachytherapy, Point A based dose delivery resulted in good Local Control and Overall Survival but it is not a true anatomical point and, hence, not a true representative of tumor volume. There is a lack of correlation between dose and outcomes. This gave scope for volume based tumor delineation and brachytherapy planning using MRI. Although MRI based tumor delineation and planning are superior, their wide applicability is limited by their availability, logistics, and financial implications. We aim to see the feasibility of using information from clinical examination and MRI information to contour target structures on CT to ensure the delivery of high doses. The primary outcome is to assess the proportion of patients achieving local control at 3 months after completion of therapy. Secondary objectives include dosimetric analysis, acute toxicities, and 2 year overall survival.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Biopsy proven squamous cell carcinoma or adenocarcinoma patients to be treated with radical chemoradiation.

排除标准

  • All postoperative patients Stage IVB disease patients Patients who are not fit for chemotherapy Patients with renal and liver diseases Immunocompromised patients.

结局指标

主要结局

Local control at 3 months after completion of therapy

时间窗: 3 months

次要结局

  • Acute toxicities
  • Late toxicity(4 months)

研究者

发起方
Dr Ramkumar R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ramkumar R

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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