EROS 3 Study Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy Brachytherapy in Terms of Overall Toxicity and Sexual Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Acute and late gastrointestinal toxicity
研究概览
简要总结
To evaluate the degree of acute and long-term intestinal, urinary and vaginal toxicity, and the impact on sexual activity of an accelerated fractionation of high dose rate interventional radiotherapy (IRT-HDR) in patients with locally advanced cervical cancer (IB2 - VA, N+/-).
详细描述
Observational, monocentric and prospective study. All patients with locally advanced cervix cancer will be underwent to radiochemotherapy followed by accelerated interventional radiotherapy (brachytherapy). Fist endpoints wer severe acute and late gastrointestinal, and urinary toxicities and sexual activity.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Histological diagnosis of squamous carcinoma and/or adenocarcinoma of the uterine cervix
- •FIGO IB2 Stadium - IVA (staging 20018)
- •No contraindications to performing MRI of the pelvis
- •Informed consent
排除标准
- •Age <18 years
- •Previous cancer in the last 10 years
- •Previous radiation treatment in the region of interest
- •Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation)
- •Presence of internal diseases that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.)
- •Presence of distant metastases in sites other than the pelvic lymph nodes
- •Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study
结局指标
主要结局
Acute and late gastrointestinal toxicity
时间窗: 6 months
Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
Acute and late urinary toxicity
时间窗: 6 months
Acute and late urinary toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
Sexual activity
时间窗: 6 months
Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
次要结局
未报告次要终点