Prophylactic Cranial Irradiation and Brain MRI Follow-up Versus Brain MRI Follow-up Alone in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Complete Remission After Definitive Radio-chemotherapy: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- 2-year brain metastasis-free survival estimated with kaplan-Meier method
研究概览
简要总结
At present, prophylactic cranial irradiation (PCI) is part of standard care for patients with limited-stage small cell lung cancer (SCLC) who have achieved good response after definitive thoracic radiotherapy and chemotherapy. However, the value of PCI is being challenged in the era when MRI examination of brain has been popularized.
The goal of this clinical study is to compare PCI and regular brain MRI follow-up (control arm) and regular brain MRI follow-up alone (study arm) in patients with limited-stage SCLC who have received definitive radiotherapy and chemotherapy and acheived complete remission (CR) of tumor.
The main questions to answer are:
- Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group.
- The difference of 2-year overall survival rate between the control group and the study group.
- Whether the patients in the study group have better overall quality of life than those in the control group.
Participants will randomly receive either PCI and regular brain MRI follow-up or regular brain MRI follow-up alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically/cytologically proven diagnosis of SCLC.
- •Age ≥ 18 years.
- •Karnofsky performance status ( KPS) ≥
- •The limited-stage is defined as the tumor confined to one side of the chest, including ipsilateral hilar, bilateral mediastinum, and bilateral supraclavicular lymph nodes. (The definition of metastatic lymph nodes is that the short diameter ≥ 1cm or PET-CT shows increased metabolism with SUV≥2.5, or proved by mediastinoscopy/EBUS/TBNA biopsy. The thickness of pleural effusion on chest CT is less than 1cm (unless cytology proves to be malignant pleural effusion). According to 8th AJCC/UICC TNM staging system, it is the I-IIIC without intrapulmonary metastasis.
- •Patients who have received definitive chest radiotherapy and chemotherapy and achieved complete remission of tumor within 4-6 weeks after the end of radio-chemotherapy (in accordance with the Response Evaluation Criteria in Solid Tumors v.1.1 including enhanced CT scan of chest and abdomen, enhanced brain MRI, bone scan and tumor markers).
- •Good follow-up compliance;
- •Fully understand this study, and voluntarily sign the informed consent form.
排除标准
- •Patients with a history of malignant tumors (past or concurrent) within 5 years, excluding papillary thyroid cancer, non-malignant melanoma skin cancer and cervical carcinoma in situ.
- •Patients who have received radical surgery (excluding biopsy).
- •Patients with psychiatric history, pregnancy and lactation.
- •Uncontrolled diabetes, hypertension, severe active infection.
- •Patients with chronic diseases of central nervous system.
- •Patients with contraindications of brain MRI examination.
- •Other situations deemed unsuitable by the doctor in charge.
研究组 & 干预措施
Control arm
Patients who are randomized to control arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive PCI and regular brain MRI follow-up.
干预措施: Prophylactic cranial irradiation (Radiation)
Control arm
Patients who are randomized to control arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive PCI and regular brain MRI follow-up.
干预措施: Thoracic radiotherapy (Radiation)
Control arm
Patients who are randomized to control arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive PCI and regular brain MRI follow-up.
干预措施: Chemotherapy (Drug)
Study arm
Patients who are randomized to study arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive regular brain MRI follow-up alone.
干预措施: Thoracic radiotherapy (Radiation)
Study arm
Patients who are randomized to study arm are those who have achieved complete remission of tumor after definitive radio-chemotherapy and will receive regular brain MRI follow-up alone.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
2-year brain metastasis-free survival estimated with kaplan-Meier method
时间窗: Up to 2 years
To test with a one-sided significance of 5% whether for the treatment of limited-stage SCLC patients, brain MRI follow-up alone is non-inferior in terms of 2-year brain metastasis-free survival compared to PCI and brain MRI follow-up. Participants were monitored for up to 2 years. The brain metastasis-free survival time is defined as the time between the date of the first treatment until the date of first documented diagnosis of brain metastasis or the date of death from any cause.
次要结局
- 2-year overall survival estimated with kaplan-Meier method(Up to 2 years)
- Intra-cranial progressive patterns(Up to 2 years)
研究者
Hu Xiao
Principal Investigator
Zhejiang Cancer Hospital