Acute and Late Toxicity After Moderate Hypo-fractionated Intensity Modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB) for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary end point is to asses acute toxicity of moderate hypo-fractionation using intensity-modulated radiotherapy (IMRT) with a simultaneous integrated boost (SIB) in prostate cancer patients
研究概览
简要总结
External radiation techniques (EBRT) is considered one of the primary therapies for patients of all risk classifications of prostate cacer . EBRT aims to control tumor growth while keeping acute and late adverse events to a minimum and ensuring biochemical progression-free outcome
详细描述
Patients and methods This is a prospective study of at least 50 patients to record acute and late toxicity using moderate hypo-fractionation with simultaneous integrated boost (SIB) IMRT for Prostate Cancer.Data will be collected at Clinical Oncology and Nuclear Medicine Department Mansoura University and Oncology Center Tanta University from January 2022 to December 2024 Patients Eligibility criteria Age >40 Pathologically proved prostate cancer Patients with unfavorable intermediate, High. very high risk groups and N1disease (Metastases in regional node(s) Risk groups according to NCCN guidelines 2021 and new grade grouping system of International Society of Urological Pathology (ISUP) Consensus Conference 2014
Unfavorable intermediate risk group :
exclusion criteria: Patients with prior pelvic irradiation. history of collagen vascular . inflammatory bowel disease. Double malignancy.
Methods Data acquisition planning computed tomography (CT) imaging will be performed in supine position using knee and ankle fixation support system for immobilization of the legs and patients arms on their chest.
Axial images will be obtained with 3-5 mm slice thickness from L1 vertebra to about 3 cm below the ischial tuberosity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age >40 Pathologically proved prostate cancer Patients with unfavorable intermediate, High. very high risk groups and N1disease (Metastases in regional node(s)
排除标准
- •Patients with prior pelvic irradiation. history of collagen vascular . inflammatory bowel disease. Double malignancy.
结局指标
主要结局
Primary end point is to asses acute toxicity of moderate hypo-fractionation using intensity-modulated radiotherapy (IMRT) with a simultaneous integrated boost (SIB) in prostate cancer patients
时间窗: Acute toxicities will be reported within the initial 18 week of starting radiotherapy
according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
次要结局
- Secondary end point is to asses late toxicity(will be recorded after 3 months of end of radiotherapy according to Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 .)
研究者
hanan fawzy
specialist of clinical oncology and nuclear medicin
Mansoura University Hospital