Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen
研究概览
简要总结
This is a prospective non-randomized clinical trial to evaluate the feasibility of 3 fraction versus a standard 4 fraction high dose rate brachytherapy regimen in patients with locally advanced cervical cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented malignancy of the cervix and planned to receive brachytherapy as part of definitive treatment.
- •ECOG performance status of 0-2
- •Age ≥ 18 years old.
- •Ability to understand and the willingness to provide written informed consent.
排除标准
- •Contraindication to receiving radiotherapy as determined by treating radiation oncologist.
- •Contraindication to receiving MRI.
- •Prior radiation to the pelvis > 3 months ago
- •Age < 18 years old.
- •Pregnant or breast-feeding
研究组 & 干预措施
Investigational Treatment
Patients who do not meet dosimetric criteria for the investigational regimen will receive the institutional standard-of-care regimen of 4 fractions (28 Gy total).
干预措施: 4-Fraction HDR Brachytherapy (Radiation)
3-Fraction Brachytherapy Arm
Patients who meet dosimetric criteria at the first brachytherapy session (HR CTV D90 > 85 Gy and acceptable OAR constraints) will receive an investigational 3-fraction HDR brachytherapy regimen (24 Gy total).
干预措施: 3-Fraction HDR Brachytherapy (Radiation)
结局指标
主要结局
Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen
时间窗: Up to 8 months
Proportion of patients that underwent a 3 fraction brachytherapy regimen.
次要结局
未报告次要终点