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:
1. Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group. 2. The difference of 2-year overall survival rate between the control group and the study group. 3. 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.
Histologically/cytologically proven diagnosis of SCLC.
Age ≥ 18 years.
Karnofsky performance status ( KPS) ≥80.
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 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.
Parallel
Prophylactic cranial irradiation
RadiationProphylactic cranial irradiation (PCI) is actually a habitual statement. It is a technique used to eliminate tiny metastatic lesions that have already existed in the brain, but can not be found by brain MRI and other inspection methods.
Thoracic radiotherapy
RadiationThoracic radiotherapy is a local treatment of tumors located in the chest using ionizing radiation.
Chemotherapy
DrugChemotherapy is the abbreviation of chemical drug therapy. It is a treatment method that uses chemical drugs to prevent the proliferation, invasion and metastasis of cancer cells, and finally kill cancer cells.
2-year brain metastasis-free survival estimated with kaplan-Meier method
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.
2-year overall survival estimated with kaplan-Meier method
To compare 2-year overall survival between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up, with kaplan-Meier estimates. Participants were monitored for up to 2 years. The overall survival time is defined as the time between the date of the first treatment until the date of death from any cause.
Intra-cranial progressive patterns
To compare the intra-cranial progressive patterns between patients who receive brain MRI follow-up alone and those who receive both PCI and brain MRI follow-up within 2 years. Intra-cranial progression is evaluated via the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In this study, Intra-cranial progressive disease is defined as the new lesions developed in the brain.
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Zhejiang Cancer Hospital
Lead sponsor
Sun Yat-sen University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
