Refining Patient Selection for Prophylactic Cranial Irradiation in Limited-Stage SCLC: A Multicenter Cohort Study.
Hye In Lee, Jae Myoung Noh, Tae Hoon Lee...
https://pubmed.ncbi.nlm.nih.gov/40769176Actively Recruiting
Led by Zhejiang Cancer Hospital · Updated on 2023-12-19
220
Participants Needed
2
Research Sites
26 weeks
Total Duration
Z
Zhejiang Cancer Hospital
Lead Sponsor
S
Sun Yat-sen University
Collaborating Sponsor
Researchers are evaluating the use of prophylactic cranial irradiation (PCI) compared to regular brain MRI follow-up alone in patients with limited-stage small cell lung cancer (SCLC) who have achieved complete remission after definitive thoracic radiotherapy and chemotherapy. The study aims to determine if MRI follow-up alone is not inferior to PCI in preventing brain metastases over two years, as well as differences in overall survival and quality of life between the two approaches. Participants are randomly assigned to one of two groups: the control group receives PCI plus regular brain MRI follow-up, while the study group undergoes regular brain MRI follow-up alone without PCI. The study focuses on patients who have finished their chest radiotherapy and chemotherapy and have shown a complete tumor response. Both interventions are monitored over a period of up to two years. During the study, participants will be regularly monitored with brain MRI scans to assess brain metastasis-free survival and overall survival rates. Researchers will also evaluate intracranial progression patterns and patients' overall quality of life. The study involves follow-up visits and clinical assessments over a two-year timeframe to gather these outcome measures and monitor participant health and safety.
CONDITIONS
PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who achieved complete remission after definitive radio-chemotherapy receive either prophylactic cranial irradiation (PCI) and regular brain MRI follow-up or regular brain MRI follow-up alone.
Regular brain MRI follow-up visits during treatment period
Total: 2 locations
1
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
X
Xiao Hu, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Hye In Lee, Jae Myoung Noh, Tae Hoon Lee...
https://pubmed.ncbi.nlm.nih.gov/40769176