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PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

NCT04790253 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2023-11-03

No results posted yet for this study

Summary

In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.

Conditions

  • Limited Stage Small Cell Lung Cancer
  • Extensive-stage Small-cell Lung Cancer

Interventions

RADIATION

Prophylactic cranial irradiation

Prophylactic cranial irradiation (PCI) is a technique used to combat the occurrence of metastasis to the brain in highly aggressive cancers that commonly metastasize to brain, most notably small-cell lung cancer.

Sponsors & Collaborators

  • UNICANCER

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Corinne Faivre-Finn, MD · The Christie NHS Foundation Trust

  • Antonin Levy, MD · Centre Gustave Roussy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

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 NCT04790253 on ClinicalTrials.gov