跳至主要内容
临床试验/CTRI/2024/06/068831
CTRI/2024/06/068831招募中不适用

High Dose Rate Interstitial Brachytherapy as Monotherapy for Extremities Soft Tissue Sarcoma: A Prospective Study

All India Institute of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
To evaluate the feasibility of interstitial brachytherapy as monotherapy in cases of extremity soft tissue sarcoma

研究概览

简要总结

Extremities soft tissue sarcoma (ESTS) are rare tumors. Treatment of ESTS has evolved significantly over the last decade. ESTS were traditionally treated with amputation and radical resections. The addition of external beam radiotherapy/ Brachytherapy has improved oncological outcomes. The current prospective study aims to study the feasibility, safety, and early oncological outcomes of Interstitial brachytherapy as monotherapy in radiation naive extremities soft tissue sarcoma post surgery. It will help us gather the acute toxicity profile, quality of life, and functional outcome data of patients of soft tissue sarcomas treated at our center with brachytherapy. The study will give our institutional data of this standard procedure, local control rates, and physician and patient-reported outcomes and help in defining standard operative procedure and pave the path of future randomized trials.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • 1.Age 18-70 years, ECOG PS 0-2 2.Biopsy-proven localized extremities soft tissue sarcoma of any Grade 3.Size up to 15 cm in the greatest dimension 4.Surgically resectable with R0 resection.

排除标准

  • Pregnant women
  • Ulcerated/Infected wound
  • Multifocal disease
  • Prior history of radiation to same /adjacent site
  • Medical or psychological illness which make them inappropriate candidate for surgery.

结局指标

主要结局

To evaluate the feasibility of interstitial brachytherapy as monotherapy in cases of extremity soft tissue sarcoma

时间窗: Data reporting on feasibility and safety at 24 months

次要结局

  • 1.To evaluate local control rates with Interstitial brachytherapy as monotherapy (IBM) is Extremity soft tissue sarcoma (ESTS)(2.To report the Adverse events at specific times using the Common Terminology Criteria for Adverse Events (CTCAE) v 6.0 , RTOG score and LENT SOMA scoring.)

研究者

发起方
All India Institute of Medical Sciences Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Bharti Devnani

AIIMS Jodhpur

研究点 (1)

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