Impact of Treatment Positioning on Radiation Therapy RTOG Toxicity in Patients With Vulvar Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- RTOG acute Skin toxicity (<3 months of starting RT)
研究概览
简要总结
The study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using Volumetric Arc Therapy (VMAT) modality with curative intent. Our aim is to compare straight-leg versus frog-leg position in terms of RTOG acute skin toxicity. Also, the study investigators will evaluate if positioning has an impact on the total treatment time and deviation on Cone Beam CT (CBCT) that might warrant re-simulation and consequently re-planning.
详细描述
Vulvar cancer is a rare tumor with a prevalence of about 3-5% of gynecological malignancies with squamous cell carcinoma being the most common histopathologic subtype. It is more common among elderly and postmenopausal women.
Surgery is the cornerstone for the management of patients with early stage vulvar cancer. Radiotherapy is an integral part of the management of vulvar cancer both in the definitive and adjuvant settings.
Several studies have shown that intensity modulated radiotherapy IMRT is associated with better locoregional control compared with 3-dimensional conformal radiotherapy 3DCRT. In addition, it is associated with dosimetric advantage and better sparing of the organs at risk.
Historically, frog-leg position was the standard to provide better access for electron boost in conventional era. After evolution of inverse planning, electron boost is not further needed. Some centers have adopted straight-leg position.
There is paucity of literature regarding vulvar cancer in general and there is lack of data addressing radiation therapy treatment position specifically.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •ECOG PS = 0-1
- •Women with Bx confirmed vulvar cancer FIGO stage I-IVA (treated with curative intent)
排除标准
- •Patients whom radiotherapy plans do not cover inguinal lymph nodes will be excluded.
- •Vulnerable patients will be excluded (pregnant)
结局指标
主要结局
RTOG acute Skin toxicity (<3 months of starting RT)
时间窗: 3 months after completion
次要结局
- Total treatment time and the need for re-planning(3 months for each patient)