Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions: Dosimetric and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Loco-regional control rate
研究概览
简要总结
Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient setting
Primary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival)
Secondary objective To determine the long-term toxicities of this regimen based on CTCAE v5
详细描述
This study is designed as a single arm phase II prospective study that will be open for recruitment for approximately 3 years. An estimated 56 cervical cancer patients treated in NUH will be recruited.
Pre-treatment Assessment
- Case reviewed in gynae multidisciplinary meeting
- Detailed gynaecologic assessment on diagnosis
- Staging scan - MRI pelvis, CT TAP or PET CT
- Baseline blood result - Full blood count, renal panel, liver panel, coagulation profile and Group screen and match
Treatment
All patients will be registered and reviewed in NUH Radiotherapy Centre. Written consent will be obtained if patient is agreeable to be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •21 years old and above
- •Histologically proven squamous cell carcinoma, adenocarcinoma, adenosquamous or poorly differentiated cervical cancer
- •Clinically or radiologically stage IB - IVA cervical cancer based on TNM 8th Edition
- •ECOG performance status 0, 1, or 2
- •To complete external beam radiotherapy and brachytherapy in NUH
- •Written, voluntary informed consent
- •Patients must be accessible for follow up and management in NUH
排除标准
- •Post operative cervical cancer cases
- •Pregnant or breastfeeding women
结局指标
主要结局
Loco-regional control rate
时间窗: 2 years from time of recruitment
Percentage of patients who recurred in the pelvis or regional lymph nodes (not in cervix).
Progression-free survival (PFS)
时间窗: 2 years from time of recruitment
Percentage of patients who develop first evidence of cancer recurrence.
Local control rate
时间窗: 2 years from time of recruitment
Percentage of patients who recurred at the site of the initial primary (the cervix).
Overall survival (OS)
时间窗: 2 years from time of recruitment
Percentage of patients who died from any cause
次要结局
- Long term toxicities(2 years from time of recruitment)