跳至主要内容
临床试验/CTRI/2021/04/032867
CTRI/2021/04/032867招募中不适用

Disease outcomes and treatment toxicities of hypofractionated radiotherapy for newly diagnosed high grade gliomas- A prospective observational study

未提供1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年4月19日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Progression Free Survival

研究概览

简要总结

Hypofractionatedradiotherapy is well-accepted alternative to conventionally fractionatedlong-course radiotherapy in elderly patients, and has been considered to haveequivalent outcomes. In the wake of present pandemic situation that hasconstrained healthcare resources, there has been increasing adoption acrossmultiple centers of hypofractionated radiotherapy schedules, significantlyreducing the overall treatment time and thereby enhanced patient safety byensuring reduced hospital visits, in addition to reducing the departmentalworkload. Moreover the hypofractionated regimen has also been shown to havecomparable response rates. In our center hypofractionated radiotherapy has beenincreasingly adopted as an option for patients preferring a shorter courseregimen. This study aims to report the outcomes of hypofractionatedradiotherapy among patients who have preferred to undergo hypofractionatedradiotherapy.

Detaileddescription of procedure/process:

Patients with high grade gliomas, following surgeryand being planned for adjuvant radiotherapy, and meeting the eligibilitycriteria, will be explained about the options of conventional (60Gy/30-33#) andhypofractionated radiotherapy (40Gy/15#). They will be recruited if they arewilling to participate in the study and provide voluntary informed consent forthe same.

Radiotherapy planning will be done on MONACOPlanning system as per the standard practice. Single phase treatment volumewill be delineated on the planning CT as per standard guidelines(1).

If eligible, patients will also receive concurrentTemozolomide during RT, and 6 months of adjuvant Temozolomide thereafter, asper the standard practice.

Thepatient and treatment details will be recorded as per the proforma. They willbe followed up following treatment as per the standard practice, of once in 3-4months for the first two years, and less frequently thereafter.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Newly diagnosed high grade glioma post resection Performance Score 2/5.

排除标准

  • Recurrent disease Poor Performance score.

结局指标

主要结局

Progression Free Survival

时间窗: 4 months,8 months and 12 months

次要结局

  • Overall Survival(Adverse effects of treatment)

研究者

发起方
未提供

研究点 (1)

Loading locations...

相似试验