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PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients
Sponsor: Zhejiang Cancer Hospital
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2023-01-01
Completion Date
2026-06
Last Updated
2023-12-19
Healthy Volunteers
No
Conditions
Interventions
Prophylactic cranial irradiation
Prophylactic 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
Thoracic radiotherapy is a local treatment of tumors located in the chest using ionizing radiation.
Chemotherapy
Chemotherapy 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.
Locations (2)
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China