Actively Recruiting
PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients
Led by Zhejiang Cancer Hospital · Updated on 2023-12-19
220
Participants Needed
2
Research Sites
178 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Cancer Hospital
Lead Sponsor
S
Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC).
- Age 18 years or older.
- Karnofsky performance status (KPS) of 80 or higher.
- Limited-stage disease confined to one side of the chest including specific lymph nodes and without intrapulmonary metastasis according to the 8th AJCC/UICC TNM staging system.
- Completed definitive chest radiotherapy and chemotherapy with complete tumor remission 4-6 weeks after treatment, confirmed by imaging and tumor markers.
- Good follow-up compliance.
- Fully understand the study and voluntarily provide informed consent.
You will not qualify if you...
- History of malignant tumors within 5 years, except papillary thyroid cancer, non-malignant melanoma skin cancer, and cervical carcinoma in situ.
- Previous radical surgery except biopsy.
- History of psychiatric illness, pregnancy, or lactation.
- Uncontrolled diabetes, hypertension, or severe active infection.
- Chronic diseases of the central nervous system.
- Contraindications to brain MRI examination.
- Any other conditions deemed unsuitable by the doctor in charge.
AI-Screening
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Trial Site Locations
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
Research Team
X
Xiao Hu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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