A Phase II Study for Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Time Taken to Induce Primary Tumor Control
研究概览
简要总结
The purpose of this study is to determine whether SABR boost therapy is effective in women with locally advanced cervical cancer without increased risk of acute gastrointestinal (GI) or genitourinary (GU) toxicity.
详细描述
Patients enrolled in this study will receive 45 Gray (Gy) in 25 fractions of intensity modulated external beam radiation therapy + weekly cisplatinum . Following the completion of Intensity Modulated Radiation Therapy (IMRT), patients will receive 28 Gy in 4 fractions using stereotactic body radiation therapy techniques.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1 Locally Advanced stage Cervical Cancer
- •Zubrod performance status 0-2
- •Negative urine or serum pregnancy test for women of child-bearing potential
- •Agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment
- •Not a candidate for intracavitary brachytherapy
排除标准
- •Concurrent untreated cancer excluding non-Melanoma skin cancer
- •Previous pelvic radiation
- •Active Inflammatory Bowel disease, Collagen vascular disease - systemic lupus erythematosus (SLE), scleroderma
- •Unable to consent for study
- •Severely immunocompromised patients ( such as Transplant , on immunosuppressive drugs)
研究组 & 干预措施
SABR Boost Therapy
干预措施: SABR Boost Therapy (Radiation)
结局指标
主要结局
Time Taken to Induce Primary Tumor Control
时间窗: 2 years
The primary objective is to improve primary tumor local control of eligible LACC using SABR as the mechanism for delivering boost therapy to 85% at 2 years post treatment
次要结局
未报告次要终点