RecruitingPhase 3NCT04829708

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

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: a Multicenter Randomized Controlled Phase III Clinical Trial


Sponsor

Shandong Cancer Hospital and Institute

Enrollment

534 participants

Start Date

Apr 26, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two strategies for people with limited-stage small cell lung cancer (SCLC) who achieved remission after chemotherapy and radiation: preventive brain radiation (called prophylactic cranial irradiation or PCI) versus regular MRI brain scans to watch for any spread. The question is whether regular monitoring can replace preventive radiation, which can have mental side effects. **You may be eligible if...** - You have limited-stage small cell lung cancer confirmed by pathology or cytology - Your cancer responded to first-line chemotherapy and radiation (complete or partial response) - You had a brain MRI within the last 4 weeks showing no cancer in the brain - You are in reasonably good health (ECOG score 0–2) - Your last treatment cycle ended no more than 8 weeks before enrolling - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Cancer has been found in your brain - Your cancer did not respond to initial treatment - You are too unwell to tolerate the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMRI Surveillance

Receive MRI surveillance

RADIATIONProphylactic Cranial Irradiation

Receive PCI


Locations(2)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, China

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NCT04829708


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