Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer: a Prospective Cohort.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Overall Acute Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
研究概览
简要总结
Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for localized prostate cancer will improve the therapeutic ratio by either:
- Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or
- Improving tumour control, mainly freedom from biochemical failure survival.
详细描述
The investigator chose to study a HypoIGRT regimen, in participants with prostate adenocarcinoma, tumor which is considered to present a low α / β, and therefore benefit from this approach.
Primary Outcome Measures:
- Acute and late radiation induced toxicities.
Secondary Outcome Measures:
- Freedom from prostate cancer recurrence - freedom from biochemical failure survival;
- Cause specific and overall survival
- Aspects of quality of life and health economics
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate
- •Patients older than 18 years old
- •Patients who accept to perform follow up in the radiation oncology department
- •Performance Status ≥ 70
- •Written informed consent
排除标准
- •Prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment
- •Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)
结局指标
主要结局
Overall Acute Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
时间窗: During and up to 90 days after treatment ends (acute event)
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Overall Acute Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
时间窗: During and up to 90 days after treatment ends (acute event)
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Overall Late Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
时间窗: After 90 days up to 24 months from treatment (late event)
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.
Overall Late Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
时间窗: After 90 days up to 24 months from treatment (late event)
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.
次要结局
- Freedom from biochemical failure survival(12 and 24 months)
- Overall Survival(12 and 24 months)
- Cause specific Survival(12 and 24 months)
- Quality of life(12 and 24 months)
研究者
Rafael Gadia
Head of Radiation Oncology - Hospital Sírio Libanês - Unidade Brasília
Hospital Sirio-Libanes