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临床试验/CTRI/2024/11/077406
CTRI/2024/11/077406尚未招募3 期

Esophageal Brachytherapy (ILRT) with Short course Hypofractionated accelerated EBRT versus EBRT alone in palliative treatment of esophageal cancers: a randomized phase III trial. (EBRISH trial)

TMH TRAC1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年1月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Degree of dysphagia would be evaluated with physician assessed 5 points Ogilvie’s score. (primary outcome)

研究概览

简要总结

Esophageal cancers often present late in their natural course of disease. In the advanced stages, many of the patients would not be suitable for treatment with a curative approach. Therefore, effective palliative treatment is necessary to decrease the burden of symptoms and improve quality of life. The ideal palliative regimen should have high rates of response with minimal toxicities. Also, patients should not be subjected to unnecessarily prolonged hospital visits. In a developing country like India, delivering effective palliative treatment with minimum hospital visits and out-of-pocket patient expenditure is crucial. One of the standard palliative external beam radiation regimens is 10 days of external beam radiotherapy (30 Grays in daily fractions over 2 weeks). However, this regimen requires at least 10 hospital visits. We wish to see if a 4 hospital visits radiation regimen combining shorter external beam radiotherapy (12 Grays in 4 fractions over 2 days, treated twice daily) with 2 sessions of intraluminal brachytherapy (12 Grays in 2 fractions) can produce potentially more relief of swallowing difficulty in esophageal patients. Decreasing treatment time would be beneficial for both the healthcare system and patients. This trial would compare the effectiveness, side effect profile, and improvement in quality of life of patients enrolled in both arms.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Age more than 18 years
  • Metastatic esophageal cancer patients or patients not suitable for radical treatment (after MDT discussion)
  • Squamous cell carcinoma or adenocarcinoma of the esophagus
  • ECOG PS 0 to 3
  • Willing to give informed consent.

排除标准

  • Upper extent of disease within 2 cm from upper esophageal sphincter
  • Lower extent of disease within 1 cm from gastroesophageal junction
  • ECOG PS 4
  • Deep ulceration
  • Trachea-esophageal fistula
  • Previous radiation therapy or surgery in the thoracic region.
  • Stents in situ before radiotherapy.

结局指标

主要结局

Degree of dysphagia would be evaluated with physician assessed 5 points Ogilvie’s score. (primary outcome)

时间窗: Ogilvie’s score-pretreatment, post-treatment, 1 month, 3 month and 6 months post treatment. (primary outcome)

次要结局

  • 2. Swallowing associated quality of life specific to the complaint of dysphagia would be evaluated with the EORTC QLC Oesophagus module(3. Treatment-associated toxicity would be associated with RTOG, CTCAE version 5 and patient-reported PRO-CTCAE.)

研究者

发起方
TMH TRAC
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Ajay Kumar Choubey

Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi

研究点 (1)

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