NCT05909137尚未招募不适用
Feasibility of Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Xinqiao Hospital of Chongqing0 个研究点目标入组 60 人开始时间: 2026年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Progression-free survival
研究概览
简要总结
Simultaneous radiotherapy followed by adjuvant immunotherapy is the standard treatment modality of unresectable stage III NSCLC. Our preliminary study confirmed that the treatment of CTV-omitted IMRT regimen did not compromise the PFS or OS and significantly reduced the incidence of severe radiation pneumonia and radiation esophagitis.
The purpose of this study was to observe the role of radiotherapy modalities that omit CTV in the context of immunotherapy for NSCLC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- ••Patients with advanced (Stage IIIA or IIIB AJCC 7) NSCLC that was histologically or cytologically inoperable
- •ECOG whole body status (performancestatus,PS) level 0 or 1
- •The estimated survival time is more than 12 weeks, 18 ~80 years old
- •Laboratory results within 2 weeks prior to radiotherapy met the following criteria: ① Neutrophil count > 1,500/ MCL Heathko-Pilot Oncology Research Fund; ② Platelet > 50,000/ MCL; ③ Total bilirubin < 1.5 times of the normal upper limit value; ④AST(SGOT)/ALT(SGPT) < 2.5 times of the normal upper limit; ⑤ Serum creatinine < 1.5 times of the normal upper limit value; ⑥ The results of coagulation function examination were within the normal range
- •Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug
- •Understand and voluntarily sign written informed consent
- •The investigator judged that the patient had good compliance
排除标准
- •Malignant pleural/pericardial effusions, previous thoracic radiotherapy or chemotherapy
- •Uncontrolled concurrent diseases, including but not limited to symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, uncontrolled diabetic blood sugar, arrhythmia, mental illness or social condition, etc.
- •Pregnant or nursing women
- •The patient has no history of intracranial hemorrhage or spinal cord hemorrhage
- •HIV-positive patients receiving combination antiretroviral therapy
- •Active tuberculosis
- •Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •Prior allogeneic stem cell or solid organ transplantation
- •Researchers determine other conditions that may affect the conduct of clinical studies and the determination of their findings
结局指标
主要结局
Progression-free survival
时间窗: through study completion，up to 12 weeks
The time between randomization and the first occurrence of disease progression or die
radiation respiratory events or esophagitis with grade 3 or higher
时间窗: after radiation therapy，up to 1 year
次要结局
- Overall survival(through study completion, an average of 2 year)
研究者
Jianguo Sun
Deputy director of oncology department，clinical professor
Xinqiao Hospital of Chongqing
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