Efficacy and Toxicity of Stereotactic Central/Core Ablative Radiation Therapy (SCART) - A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This study is expected to enroll patients for a period of five years, with a total of 30 participants. It is a prospective observational study involving cancer patients with tumors having a longest diameter greater than or equal to 5 cm. Systemic drug therapy may be administered concurrently. The following inclusion criteria must be met for participation in the study: age greater than or equal to 18 years, Eastern Cooperative Oncology Group (ECOG) score ≤ 2, pathological confirmation of cancer diagnosis, tumor with a maximum diameter greater than or equal to 5 cm, one or more lesions, not suitable for surgery, patient has provided informed consent, patient receives SCART, and reproductive-age women must agree to take adequate contraceptive measures during the study and for six months after discontinuation of medication. The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor gross target volume (GTV) boundary. For certain patients, an additional two fractions of 5 Gy each were added using Stereotactic Body Radiotherapy (SBRT), resulting in a total dose of 5 Gy × 5 for the GTV boundary.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •ECOG score ≤ 2, pathological confirmation of cancer diagnosis
- •Pathologically proved malignant tumor with a maximum diameter greater than or equal to 5 cm
- •One or more lesions, not suitable for surgery
- •Patient has provided informed consent
排除标准
- •Life expectancy less than six months
- •Uncontrolled angina, arrythmia, and congestive heart failure
- •History of malignant pleural effusion
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From date of radiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
the time from inclusion to disease progression or death from any cause.
Local Control (LC)
时间窗: From date of radiotherapy until the date of first documented progression, assessed up to 60 months
a tumor volume equal to or less than the tumor volume at start of radiotherapy
次要结局
未报告次要终点
研究者
Hao-Shen Cheng
Attending Physician
Taichung Veterans General Hospital