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临床试验/NCT03853733
NCT03853733招募中不适用

Palliative Hypofractionated Radiotherapy in Non-operable Rectal Cancer: A Retrospective Study

Consorci Sanitari de Terrassa1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Symptomatic response after palliative radiotherapy (bleeding)

研究概览

简要总结

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

详细描述

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

Patients with rectal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis were considered eligible.

Patients were immobilized in the prone position with a belly-board in order to reduce small bowel irradiation. To limit organ motion patient were instructed to empty the bladder and drink 500cm3 of water 45-60 minutes before CT simulation and before every treatment fraction.

A conformal three-dimensional radiotherapy technique was planned to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.

Symptomatic response after the end of treatment has been measured for bleeding and pain and acute toxicity were reported according to CTCAEv4.0 scale.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Symptomatic response after palliative radiotherapy (bleeding)

时间窗: two months afer the end of radiotherapy

number of patients with bleeding ( worst, no change, better or without)

Symptomatic response after palliative radiotherapy (pain)

时间窗: two months afer the end of radiotherapy

number of patients with pain ( worst, no change, better or without)

Genitourinary toxicity after the end of radiotherapy

时间窗: two months afer the end of radiotherapy

Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.

Gastrointestinal toxicity after the end of radiotherapy

时间窗: two months afer the end of radiotherapy

Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale

次要结局

  • palliative colostomy after the end of palliative radiotherapy(two months afer the end of radiotherapy)

研究者

发起方
Consorci Sanitari de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joan Lozano Galan

Principal Investigator

Consorci Sanitari de Terrassa

研究点 (1)

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