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

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.

Trial Details

NCT ID
NCT04829708
Phase
PHASE3
Sponsor
Shandong Cancer Hospital and Institute
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • MRI Surveillance
  • Prophylactic Cranial Irradiation
Locations (sample)
  • Jinan, Shandong, China|36.66833,116.99722
  • Jinan, China|36.66833,116.99722

Key Eligibility Criteria

  • Histological or cytological confirmation of LS-SCLC before first-line chemoradiotherapy (according to the staging system of the Veterans' Affairs L…
  • Remission is achieved after first-line chemoradiotherapy (CR or PR determined by RECIST v1.1)；
  • Brain MRI examination should be performed to exclude metastatic lesions of brain parenchyma and meninges within four weeks before enrollment；
  • The ECOG PS score was 0\~2；

For full eligibility, visit ClinicalTrials.gov.

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