A Single-Arm Clinical Study Evaluating the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adults With Nasal and Paranasal Sinus Rhabdomyosarcoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Given the rarity of nasal and paranasal sinus rhabdomyosarcoma (SNRMS), there is a lack of literature on systemic treatment models for adult SNRMS, let alone prospective clinical studies. After referring to the literature, combining clinical practice and summarizing the previous treatment data of our center, we plan to conduct a prospective clinical trial: a study on the treatment of adult SNRMS with induction chemotherapy combined with radical chemoradiotherapy followed by adjuvant chemotherapy and surgery. The cumulative chemotherapy course is 8 (4 courses before radiotherapy and 4 courses after radiotherapy), and the total radiotherapy dose is 62-66Gy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years old, gender not limited.
- •Pathologically confirmed as rhabdomyosarcoma of the nasal cavity and paranasal sinuses.
- •First-time treatment patients.
- •Distant metastasis was ruled out through a comprehensive physical examination.
- •Cases that met the inclusion criteria after joint discussion with rhinologists.
- •Expected survival period ≥6 months.
- •ECOG score: 0-2.
排除标准
- •Patients whose distant metastasis has been clearly identified.
- •Previously, chemotherapy, immunotherapy or biological targeted therapy has been applied to the target lesion; Patients whose target lesions have received radiotherapy or surgery (excluding biopsy).
- •Functional impairment of vital organs
结局指标
主要结局
ORR
时间窗: up to 24 weeks
Objective Response Rate; The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time frame required by accepted response evaluation criteria, such as Solid Tumor RECIST Version 1.1.
次要结局
- PFS(up to 5 year)
- OS(up to 5 year)