Actively Recruiting
Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy
Led by Shandong Cancer Hospital and Institute · Updated on 2021-04-29
534
Participants Needed
2
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open,multicenter, randomized controlled phase III clinical trial. In patients with LS-SCLC who achieve remission after first-line chemoradiotherapy, the efficacy and safety of PCI or MRI surveillance is evaluated and analyzed. PCI is performed in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. MRI surveillance alone (delaying radiation until the actual brain metastasis) may be not inferior to PCI.
CONDITIONS
Official Title
Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of limited-stage small cell lung cancer before first-line chemoradiotherapy
- Achieved remission (complete or partial response) after first-line chemoradiotherapy
- Brain MRI performed within 4 weeks before enrollment showing no brain metastasis
- ECOG performance status score of 0 to 2
- Time between last treatment cycle and randomization no more than 8 weeks
- Estimated survival time of at least 12 weeks
- Male or female aged 18 to 75 years old
- Agreement to participate and comply with study procedures with written informed consent
- Fertile men and women agree to abstinence or effective contraception during treatment and for 6 months after
- Hematological function with specified minimum counts and levels
- Liver function within specified limits
- Renal function within specified limits
- Good blood clotting function within specified limits
- Women of childbearing age must have a negative pregnancy test within 7 days before treatment and not be breastfeeding
You will not qualify if you...
- Extensive small cell lung cancer
- Brain or meningeal metastasis before randomization
- Other malignant tumors within 5 years except those with negligible metastasis risk or cured cancers
- Prior radiation overlapping PCI field
- Contraindications to MRI
- Uncontrolled serious diseases affecting study compliance (severe liver disease, seizures, superior vena cava syndrome)
- Recent major cardiovascular events or unstable heart conditions
- Stroke or transient ischemic attack within 6 months
- Significant bleeding or bleeding tendency within 1 month
- Recent serious thromboembolism events within 3 months
- Diabetic ketoacidosis or hyperosmolar state within 6 months
- History of hypertensive crisis or encephalopathy
- Any condition that may affect study results or increase treatment risks
- Positive HIV test
- Major surgery within 28 days before study or expected during study
- Severe infections requiring hospitalization at study start
- Pregnant or breastfeeding women
- Severe neurological or mental disorders affecting assessment
- Any condition affecting study efficacy evaluation or patient compliance
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
Actively Recruiting
2
Shandong Cancer Hospital
Jinan, China
Actively Recruiting
Research Team
J
Jinming Yu, PhD
CONTACT
X
Xiangjiao Meng, 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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