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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

NCT04829708 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2021-04-29

No results posted yet for this study

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.

Conditions

  • Limited Stage Small Cell Lung Cancer

Interventions

OTHER

MRI Surveillance

Receive MRI surveillance

RADIATION

Prophylactic Cranial Irradiation

Receive PCI

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Principal Investigators

  • Jinming Yu, PhD · Shandong Cancer Hospital and Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2026-04-15
Completion
2028-04-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829708 on ClinicalTrials.gov