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临床试验/CTRI/2024/08/072042
CTRI/2024/08/072042招募中不适用

Prospective Registry for Skeletal Metastasis treated with Palliative intent Radiation

Homi Bhabha Cancer Hospital and Research Center, Tata Memorial Centre, Visakhapatnam1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月19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
200
试验地点
1
主要终点
To Assess incidence of Skeletal Related events (SRE)

研究概览

简要总结

The third most common organ to be affected by metastatic disease is bone, which is a frequent manifestation of advanced malignancy. Bone metastases (BM) lead to several morbidities and lower quality of life. Patients with BM are susceptible to high rates (50-70%) of complications such as paraplegia, fractures, and acute or chronic pain. It has been observed that these complications can be reduced by certain bone-modifying agents such as bisphosphonates and Radiotherapy (RT). Research studies have shown that RT substantially decreases complications in symptomatic or high-risk asymptomatic BM disease patients. So in this observational study, we aim to evaluate skeletal-related events (SRE) in both symptomatic and high-risk asymptomatic BM (>50% cortical destruction, > 3 cm maximum diameter, axial cortical involvement of > 3 cm, multi-focal lytic lesion) patients treated with RT. Patients with histologically confirmed malignancy diagnosis with BM and fulfilling inclusion criteria will be screened and invited to participate. Those who give written informed consent will be enrolled in the study. Incidence of SRE will be assessed initially at 6 months. SRE constitutes spinal cord compression, pathological fractures, and /or orthopedic surgery in the irradiated bony region. Pain response and analgesic usage patterns will be evaluated, and post-RT acute and late toxicities will be documented as per Common Toxicities Criteria for Adverse Events (CTCAE) v5.0.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients with histologically confirmed malignancy with symptomatic metastatic bone disease detected on cross sectional imaging b.
  • If bone metastases are asymptomatic or minimally symptomatic (without opioid need) will be considered as high risk bone metastases if any of the following criteria is met:
  • More than 50% cortical destruction
  • More than 3 cm maximum diameter
  • Axila cortical involvement more than 3 cm
  • Multifocal lytic disease.

排除标准

  • Patients who had previously received radiation therapy in the study region concerned.
  • Patients with any comorbidities that attributes to the present symptoms (intervertebral disc prolapse, spinal cord compression, and fractures post-spinal fixation)
  • Leptomeningeal disease.
  • Serious medical co-morbidities that preclude RT.
  • Patients who are diagnosed with prostate & haematolymphoid malignancy.

结局指标

主要结局

To Assess incidence of Skeletal Related events (SRE)

时间窗: 6 months

次要结局

  • To Evaluate pain response in patients with Symptomatic bone metastasis(6 months)
  • To evaluate patterns of analgesic usage in patients with symptomatic bone metastasis(6 months)
  • To document post-radiation acute toxicities(3 months)
  • To document post-radiation late toxicities(12 months)

研究者

发起方
Homi Bhabha Cancer Hospital and Research Center, Tata Memorial Centre, Visakhapatnam
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Umesh Mahantshetty

Homi Bhabha Cancer Hospital and Research Center

研究点 (1)

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