NCT04351282尚未招募不适用
SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Primary metastatic NPC patients received chemotherapy± immunotherapy, radiation for primary tumors and SBRT for metastatic lesions.
详细描述
The eligible patients will receive 4-6 cycles chemotherapy±immunotherapy and radical radiotherapy for nasopharyngeal tumors. Then, SBRT for oligometastatic lesions will be assigned to eligible patients. The efficacy and side-effect will be evaluated and analyzed. The relation of liquid biopsy data with treatment outcome（such as EBV DNA, CTCs, CTC subtype，PD-L1 and so on）will be valued.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically conformed initial metastatic non-keratinizing nasopharyngeal carcinoma (according to the 8th edition of AJCC/UICC stage system) and no PD was observed in eligible patients after comprehensive treatment (chemotherapy±immunotherapy+radiotherapy to primary tumor). Then, the metastic lesions were PR/SD, and met the following requirement: the metastatic lesions ≤5 and metastatic organs ≤2, no more than 3 metastastic lesions for a single organ (diameter ≤ 5cm)
- •age 18-70 years old
- •Karnofsky scores ≥70
- •Estimated life ≥ 6 months
- •Adequate organ function including the following: Absolute neutrophil count (ANC) >= 2.0 * 109/l; Platelets count >= 100 * 109/l ;Hemoglobin >= 90 g/dl; Creatinine clearance >= 60 ml/min; For patients without liver metastasis, AST and ALT <= 1.5 times institutional upper limit of normal (ULN), Total bilirubin <= 1.5 times institutional ULN; For patients with liver metastasis, AST and ALT <= 3 times institutional upper limit of normal (ULN), Total bilirubin <= 3 times institutional ULN, with normal coagulation function, child-pugh grade A or B, normal liver tissue volume >700 mL
- •Signed written informed consent
排除标准
- •Patients who achieve complete remission after comprehensive treatment
- •Pathology confirmed as second primary tumor
- •Received radiotherapy at the corresponding site before, and overlapped with the site of this radiotherapy
- •Femoral bone metastasis
- •With serious medical complications and contraindications of radiotherapy
- •With uncontrollable malignant pleural effusion
- •Positive pregnancy test for women of childbearing age or lactating women
- •Uncontrolled or active infections, such as immunodeficiency or HIV infection
- •Active mental disorder or other mental disorder that affects the patient's ability to sign informed consent and understanding.
结局指标
主要结局
Overall survival
时间窗: up to 3 years
From date of diagnosis until the date of death from any cause
次要结局
- Progress free survival(up to 3 years)
- New Metastatic Free Survival(up to 3 years)
- Previous Metastatic Progression Free Survival(up to 3 years)
- Adverse Event(up to 3 years)
研究者
研究点 (1)
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